Alzheimer's DiseasePhase 3IDENTITY-2NCT00762411

Effects of LY450139, on the Progression of Alzheimer's Disease as Compared With Placebo

A Phase 3 study testing LY450139 in people with Alzheimer's Disease, run by Eli Lilly and Company at 91 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 55 years and older
Conditions the study is for: Alzheimer's Disease
What is being tested?: LY450139
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,111 participants
Where: 91 sitesin 18 countries
Study dates: Sep 2008to Apr 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Meets criteria for mild to moderate Alzheimer's disease (AD) with Mini-Mental State Examination score of 16 through 26 at visit 1
Modified Hachinski Ischemia Scale score of less than or equal to 4
Geriatric Depression Scale score of less than or equal to 6
A magnetic resonance imaging (MRI) or computerized tomography (CT) scan in the last 2 years with no findings inconsistent with a diagnosis of AD
If female, must be without menstruation for a least 12 consecutive months or have had both ovaries removed.

Who cannot join

Is not capable of swallowing whole oral medication
Has serious or unstable illnesses
Does not have a reliable caregiver
Chronic alcohol and/or drug abuse within the past 5 years
Has ever had a active vaccination for AD

Trial locations and contacts

91 sites in 18 countries.

Country

City, postcode or hospital

91 sites in 18 countries

United States22 sites

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Albany, New York, 12205
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Boca Raton, Florida, 33431
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Costa Mesa, California, 92626
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Durham, North Carolina, 27710
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Hallandale, Florida, 33009
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Hattiesburg, Mississippi, 39401
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Hollywood, Florida, 33021
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La Jolla, California, 92037
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Laguna Hills, California, 92653
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Los Angeles, California, 90036
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Manhasset, New York, 11030
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Miami, Florida, 33137
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New Orleans, Louisiana, 70131
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Oklahoma City, Oklahoma, 73103
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Omaha, Nebraska, 68105
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Orlando, Florida, 32806
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Oxnard, California, 93030
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Philadelphia, Pennsylvania, 19131
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Phoenix, Arizona, 85004
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San Francisco, California, 94109
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Shreveport, Louisiana, 71104
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Tampa, Florida, 33609

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Japan12 sites

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Akita, 010-0874
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Fukuoka, 814-0180
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Hyōgo, 655-0037
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Ibaraki, 305-8576
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Kanagawa, 251-0038
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Kumamoto, 861-8002
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Kyoto, 606-0851
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Nagasaki, 852-8108
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Numakunai, 020-8505
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Osaka, 599-8263
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Saitama, 344-0036
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Tokyo, 113-8655

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Canada9 sites

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Greenfield Park, Quebec, J4V 2J2
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London, Ontario, N6C 5J1
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Montreal, Quebec, H1T 2M4
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Ottawa, Ontario, K1N 5C8
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Peterborough, Ontario, K9H2P4
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Saint John, New Brunswick, E2L 3L6
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Toronto, Ontario, M3B2S7
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Verdun, Quebec, H4H 1R3
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Winnipeg, Manitoba, R3N 0K6

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Germany5 sites

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Berlin, 10629
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Frankfurt, 60528
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Hamburg, 22083
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Heidelberg, 69115
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Mannheim, 68165

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Ukraine5 sites

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Dnipropetrovsk, 49616
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Donetsk, 83037
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Kherson, 73488
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Kyiv, 04080
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Odesa, 65006

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France4 sites

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Montpellier, 34295
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Paris, 75651
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Poitiers, 86021
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Strasbourg, 67091

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Italy4 sites

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Boggiovara, 41100
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Cassino, 03043
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Milan, 20122
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Parma, 43100

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Russia4 sites

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Kazan', 420101
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Saint Petersburg, 190021
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Saratov, 410028
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Yekaterinburg, 620030

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Taiwan4 sites

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Changhua, 500
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Tainan, 70403
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Taipei, 111
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Taoyuan, 333

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Turkey (Türkiye)4 sites

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Eskişehir, 26480
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Istanbul, 34452
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Izmir, 35340
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Samsun

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Brazil3 sites

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Rio de Janeiro, 21020-130
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Salvador, 40301500
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São Paulo, 040024-002

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China3 sites

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Beijing, 100853
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Shanghai, 200025
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Xi'an, 710038

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Mexico3 sites

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Aguascalientes, 20217
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Monterrey, 64710
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Saltillo, 25000

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Hungary2 sites

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Budapest, H-1083
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Esztergom, 2500

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Romania2 sites

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Bucharest, 011241
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Timișoara, 300736

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Serbia2 sites

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Belgrade, 11000
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Kragujevac, 34000

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South Korea2 sites

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Seoul, 139-707
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Suwon, 443-721

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Bulgaria1 site

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Sofia, 1527

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About this study

Official title: Effect of LY450139 a y-Secretase Inhibitor, on the Progression of Alzheimer's Disease as Compared With Placebo

Alzheimer's disease (AD) is a fatal degenerative disease of the brain for which there is no cure. AD causes brain cells to die. AD is thought to be caused by an excess of beta amyloid (β-amyloid), a sticky protein in the brain that forms amyloid plaques. At autopsy, AD patients are required to have these amyloid plaques in the brain in order to have a definitive diagnosis of AD. Inhibiting the enzyme gamma-secretase (γ-secretase) lowers the production of β-amyloid. Semagacestat (LY450139) is a functional γ-secretase inhibitor and was shown to lower β-amyloid in blood and spinal fluid in humans tested thus far and in blood, spinal fluid and brain in animals tested thus far. This study used several different tests to measure the effect of semagacestat on both β-amyloid and amyloid plaques for some patients. The buildup of amyloid plaques was measured by a brain scan that takes a picture of amyloid plaques in the brain. Other tests measured the overall function of the brain and brain size in some patients. In this trial, patients who initially received placebo (inactive sugar pill) were, at a certain point in the study, switched over to active drug, semagacestat. In other words, all patients could eventually receive active drug. Each patient's participation could last approximately 2 years. Patients taking approved AD medications were permitted to participate in this study and continue taking these medications during the study. All patients who completed this study had the option to continue receiving semagacestat by participating in an open label study.

Preliminary results from this study (LFBC) (and another similar study LFAN [NCT00594568]) showed semagacestat did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. Study drug was stopped in all studies. LFBC, LFAN and open label LFBF (NCT01035138) have been amended to continue collecting safety data, including cognitive scores, for at least seven months. The CT-Registry will reflect results of analyses from the original protocol in addition to those from the amended protocol.

Conditions: Alzheimer's Disease
Being tested: LY450139, Placebo
Keywords: Alzheimer's Disease
Medical subject headings: Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY450139Drug
Also called Semagacestat
Administered orally once daily.
PlaceboDrug
Administered orally once daily.

Study groups in NCT00762411
Study group	Role	What they receive
LY450139	Experimental	Participants received 60 milligrams (mg) LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88. Receives: Drug: LY450139
Placebo	Placebo comparator	Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog11) at 76 Weeks
The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Measured: Baseline (randomization), 76 weeks
Change From Baseline in Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog11) at 16 Weeks After Cessation of Study Drug
The cognitive subscale of ADAS (ADAS Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Measured: Baseline (randomization), 16 weeks following treatment cessation
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at 76 Weeks
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Measured: Baseline (randomization), 76 weeks
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at 16 Weeks After Cessation of Study Drug
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Measured: Baseline (randomization), 16 weeks following treatment cessation

Secondary outcomes (25)

Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) at 76 Weeks
CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Measured: Baseline (randomization), 76 weeks
Change From Baseline in Neuropsychiatric Inventory (NPI) at 76 Weeks
NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. Total score ranges from 12 to 144; higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Measured: Baseline (randomization), 76 weeks
Change From Baseline in the Resource Utilization in Dementia-Lite (RUD-Lite) up to 76 Weeks
Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (care-giving time, work status) and participants (accommodation and healthcare resource utilization) was gathered from baseline and follow-up interviews. Reported number of hospitalizations per participant up to 76 weeks. Least Squares (LS) Mean value was controlled for age and investigator.
Measured: Baseline (randomization), up to 76 weeks
Change From Baseline in the EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) at 76 Weeks
EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Numerals 1-3 are not added for total score. VAS assesses caregiver's impression of participant's overall health state; scores range: 0 to 100. Lower scores indicate greater disease severity. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Measured: Baseline (randomization), 76 weeks
Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) at 76 Weeks
Assess QoL for AD: participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items, rated on a 4-point scale. Sum of items=total score (range: 13 to 52). Higher scores indicate greater QoL. Participant's primary caregiver asked to complete same measure. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Measured: Baseline (randomization), 76 weeks
Change From Baseline in Mini Mental State Examination (MMSE) at 76 Weeks
MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges from 0 to 30; lower score indicates greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication
Measured: Baseline (randomization), 76 weeks
Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at 52 Weeks
Concentration of amino acid peptide known as Aβ 1-42 in plasma. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Measured: Baseline (randomization), 52 weeks
Change From Baseline in Positron Emission Tomography (PET) Using Fluorine-18 Fluorodeoxyglucose (18F-FDG) at 76 Weeks
Measurement of local cerebral glucose metabolism by PET using the radioactive tracer 18F-FDG. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the Pons. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Measured: Baseline (randomization), 76 weeks
Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) up to 76 Weeks
The vMRI assessment of right and left hippocampal volume is reported. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Measured: Baseline (randomization), up to 76 weeks
Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45 PET) up to 76 Weeks
A radioactive tracer for PET that is a ligand for amyloid called [18F]-AV-45. This permits the visualization of amyloid in the brains of Alzheimer's participants. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the cerebellar gray matter. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Measured: Baseline (randomization), up to 76 weeks
Change From Baseline in Tau Concentration in Spinal Fluid up to 76 Weeks
Concentration of total tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Measured: Baseline (randomization), up to 76 weeks
LY450139 Population Pharmacokinetics: Clearance of LY450139
Model estimated apparent oral clearance. Clearance is defined as the volume of plasma which is completely cleared of drug (LY450139) per unit time.
Measured: 6 weeks, 12 weeks, and 52 weeks
LY450139 Population Pharmacokinetics: Volume of Distribution of LY450139
Model-estimated apparent volume of distribution. Volume of distribution is a measure of the extent to which drug distributes in the body.
Measured: 6 weeks, 12 weeks, and 52 weeks
Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) at 4 Weeks After Cessation of Study Drug
Semi-structured interview. Participant's cognitive status rated across 6 domains of functioning: memory, orientation, judgment/problem solving, community affairs, home/hobbies, personal care. Severity score assigned for each of 6 domains; total score (SB) ranges: 0 to 18. Higher scores=greater disease severity. Least Squares Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care medication. LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants followed off-dose for 32 weeks, but CDR-SB not assessed.
Measured: Baseline (randomization), 4 weeks following treatment cessation
Change From Baseline in Neuropsychiatric Inventory (NPI) at 4 Weeks After Cessation of Study Drug
NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with participant's behavior. Total score ranges from 12 to 144; higher scores indicate greater disease severity. The Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but NPI was not assessed.
Measured: Baseline (randomization), 4 weeks following treatment cessation
Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) at 4 Weeks After Cessation of Study Drug
Assesses healthcare resource utilization (formal and informal care). Information gathered on both care-giving time, work status) and participants (accommodation, healthcare resource utilization) is collected. Reported number of participant hospitalizations. Least Squares (LS) Mean value controlled for age and investigator. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but RUD-Lite was not assessed.
Measured: Baseline (randomization), 4 weeks following treatment cessation
Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) at 4 Weeks After Cessation of Study Drug
EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 3 severity levels: no, some, severe problems. VAS assesses caregiver's impression of participant's health state; score ranges: 0 to 100. Lower scores=greater disease severity. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but EQ-5D VAS was not assessed.
Measured: Baseline (randomization), 4 weeks following treatment cessation
Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) at 4 Weeks After Cessation of Study Drug
Assess QoL for AD; participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items rated on a 4-point scale. Sum of items=total score (range: 13-52). Higher scores=greater QoL. Participant's primary caregiver asked to complete same measure. Least Squares Mean value controlled for baseline, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but QoL-AD not assessed.
Measured: Baseline (randomization), 4 weeks following treatment cessation
Change From Baseline in Mini Mental State Examination (MMSE) 4 Weeks After Cessation of Study Drug
Used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges: 0 to 30. Lower score indicates greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but MMSE was not assessed.
Measured: Baseline (randomization), 4 weeks following treatment cessation
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) at 76 Weeks
ADAS-Cog12 is ADAS-Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Measured: Baseline (randomization), 76 weeks
Change From Baseline in Alzheimer's Disease Assessment Scale (ADAS-Cog14) at 76 Weeks
ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Measured: Baseline (randomization), 76 weeks
Change From Baseline in Phosphorylated-Tau (P-tau) Concentration in Spinal Fluid up to 76 Weeks
Concentration of p-tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Measured: Baseline (randomization), up to 76 weeks
Change From Baseline in Amyloid Beta (Aβ) 1-42 Concentration in Spinal Fluid up to 76 Weeks
Concentration of an amino acid peptide known as Aβ 1-42 in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Measured: Baseline (randomization), up to 76 weeks
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) at 16 Weeks After Cessation of Study Drug
ADAS-Cog12 is ADAS-Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Measured: Baseline (randomization), 16 weeks following treatment cessation
Change From Baseline in Alzheimer's Disease Assessment Scale (ADAS-Cog14) at 16 Weeks After Cessation of Study Drug
ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, concomitant standard of care (SOC) medication.
Measured: Baseline (randomization), 16 weeks following treatment cessation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008Apr 2011

First posted30 Sep 2008 (estimated)
Study startSep 2008
Primary completionApr 2011
Study completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,111 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00762411
Sponsor's protocol ID: 11271
Other IDs: H6L-MC-LFBC
Acronym: IDENTITY-2
Status last verified: Jan 2015
First submitted: 26 Sep 2008
Last updated: 16 Feb 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Liu-Seifert H, Siemers E, Price K, Han B, Selzler KJ, Henley D, Sundell K, Aisen P, Cummings J, Raskin J, Mohs R; Alzheimer's Disease Neuroimaging Initiative. Cognitive Impairment Precedes and Predicts Functional Impairment in Mild Alzheimer's Disease. J Alzheimers Dis. 2015;47(1):205-14. doi: 10.3233/JAD-142508.
PubMed 26402769
Henley DB, Dowsett SA, Chen YF, Liu-Seifert H, Grill JD, Doody RS, Aisen P, Raman R, Miller DS, Hake AM, Cummings J. Alzheimer's disease progression by geographical region in a clinical trial setting. Alzheimers Res Ther. 2015 Jun 25;7(1):43. doi: 10.1186/s13195-015-0127-0. eCollection 2015.
PubMed 26120369

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of LY450139 a y-Secretase Inhibitor, on the Progression of Alzheimer's Disease as Compared With Placebo
ClinicalTrials.gov ID: NCT00762411
Acronym / sponsor ID: IDENTITY-2 / 11271
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,111 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 30 Sep 2008 (estimated)
Results: Posted 25 Sep 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
LY450139	Experimental	Drug: LY450139Participants received 60 milligrams (mg) LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Placebo	Placebo comparator	Drug: PlaceboParticipants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Meets criteria for mild to moderate Alzheimer's disease (AD) with Mini-Mental State Examination score of 16 through 26 at visit 1
Modified Hachinski Ischemia Scale score of less than or equal to 4
Geriatric Depression Scale score of less than or equal to 6
A magnetic resonance imaging (MRI) or computerized tomography (CT) scan in the last 2 years with no findings inconsistent with a diagnosis of AD
If female, must be without menstruation for a least 12 consecutive months or have had both ovaries removed.

Key exclusion criteria (5 listed)

Is not capable of swallowing whole oral medication
Has serious or unstable illnesses
Does not have a reliable caregiver
Chronic alcohol and/or drug abuse within the past 5 years
Has ever had a active vaccination for AD

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY450139Also: SemagacestatAdministered orally once daily.	Drug	LY450139
PlaceboAdministered orally once daily.	Drug	Placebo

Primary outcome

Change From Baseline in Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog11) at 76 Weeks
Time frame: Baseline (randomization), 76 weeks
The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Change From Baseline in Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog11) at 16 Weeks After Cessation of Study Drug
Time frame: Baseline (randomization), 16 weeks following treatment cessation
The cognitive subscale of ADAS (ADAS Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at 76 Weeks
Time frame: Baseline (randomization), 76 weeks
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at 16 Weeks After Cessation of Study Drug
Time frame: Baseline (randomization), 16 weeks following treatment cessation
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.

25 secondary outcomes

Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) at 76 Weeks
Time frame: Baseline (randomization), 76 weeks
Change From Baseline in Neuropsychiatric Inventory (NPI) at 76 Weeks
Time frame: Baseline (randomization), 76 weeks
Change From Baseline in the Resource Utilization in Dementia-Lite (RUD-Lite) up to 76 Weeks
Time frame: Baseline (randomization), up to 76 weeks
Change From Baseline in the EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) at 76 Weeks
Time frame: Baseline (randomization), 76 weeks
Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) at 76 Weeks
Time frame: Baseline (randomization), 76 weeks
Change From Baseline in Mini Mental State Examination (MMSE) at 76 Weeks
Time frame: Baseline (randomization), 76 weeks
Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at 52 Weeks
Time frame: Baseline (randomization), 52 weeks
Change From Baseline in Positron Emission Tomography (PET) Using Fluorine-18 Fluorodeoxyglucose (18F-FDG) at 76 Weeks
Time frame: Baseline (randomization), 76 weeks
Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) up to 76 Weeks
Time frame: Baseline (randomization), up to 76 weeks
Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45 PET) up to 76 Weeks
Time frame: Baseline (randomization), up to 76 weeks
Change From Baseline in Tau Concentration in Spinal Fluid up to 76 Weeks
Time frame: Baseline (randomization), up to 76 weeks
LY450139 Population Pharmacokinetics: Clearance of LY450139
Time frame: 6 weeks, 12 weeks, and 52 weeks
LY450139 Population Pharmacokinetics: Volume of Distribution of LY450139
Time frame: 6 weeks, 12 weeks, and 52 weeks
Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) at 4 Weeks After Cessation of Study Drug
Time frame: Baseline (randomization), 4 weeks following treatment cessation
Change From Baseline in Neuropsychiatric Inventory (NPI) at 4 Weeks After Cessation of Study Drug
Time frame: Baseline (randomization), 4 weeks following treatment cessation
Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) at 4 Weeks After Cessation of Study Drug
Time frame: Baseline (randomization), 4 weeks following treatment cessation
Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) at 4 Weeks After Cessation of Study Drug
Time frame: Baseline (randomization), 4 weeks following treatment cessation
Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) at 4 Weeks After Cessation of Study Drug
Time frame: Baseline (randomization), 4 weeks following treatment cessation
Change From Baseline in Mini Mental State Examination (MMSE) 4 Weeks After Cessation of Study Drug
Time frame: Baseline (randomization), 4 weeks following treatment cessation
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) at 76 Weeks
Time frame: Baseline (randomization), 76 weeks
Change From Baseline in Alzheimer's Disease Assessment Scale (ADAS-Cog14) at 76 Weeks
Time frame: Baseline (randomization), 76 weeks
Change From Baseline in Phosphorylated-Tau (P-tau) Concentration in Spinal Fluid up to 76 Weeks
Time frame: Baseline (randomization), up to 76 weeks
Change From Baseline in Amyloid Beta (Aβ) 1-42 Concentration in Spinal Fluid up to 76 Weeks
Time frame: Baseline (randomization), up to 76 weeks
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) at 16 Weeks After Cessation of Study Drug
Time frame: Baseline (randomization), 16 weeks following treatment cessation
Change From Baseline in Alzheimer's Disease Assessment Scale (ADAS-Cog14) at 16 Weeks After Cessation of Study Drug
Time frame: Baseline (randomization), 16 weeks following treatment cessation

Results and safety

Results posted to the registry on 25 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
140 mg LY450139	556	22
Placebo	555	34

Primary outcome: Change From Baseline in Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog11) at 76 Weeks

Time frame: Baseline (randomization), 76 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	140 mg LY450139 n = 555	Placebo n = 553
Value	7.37 (0.79)	6.77 (0.72)

140 mg LY450139 vs Placebo: p = 0.560, Mixed Models Analysis

Population analysed: Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.

Primary outcome: Change From Baseline in Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog11) at 16 Weeks After Cessation of Study Drug

Time frame: Baseline (randomization), 16 weeks following treatment cessation. Least squares mean (Standard Error). Unit: units on a scale

Measure	140 mg LY450139 n = 312	Placebo n = 430
Value	4.81 (0.70)	4.85 (0.63)

140 mg LY450139 vs Placebo: p = 0.959, Mixed Models Analysis

Population analysed: Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.

Primary outcome: Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at 76 Weeks

Time frame: Baseline (randomization), 76 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	140 mg LY450139 n = 555	Placebo n = 553
Value	-10.49 (0.98)	-9.77 (0.90)

140 mg LY450139 vs Placebo: p = 0.567, Mixed Models Analysis

Population analysed: Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.

Primary outcome: Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at 16 Weeks After Cessation of Study Drug

Time frame: Baseline (randomization), 16 weeks following treatment cessation. Least squares mean (Standard Error). Unit: units on a scale

Measure	140 mg LY450139 n = 312	Placebo n = 430
Value	-8.88 (0.93)	-7.68 (0.84)

140 mg LY450139 vs Placebo: p = 0.199, Mixed Models Analysis

Population analysed: Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.

25 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo- (Initial Treatment Period [NT])	60 of 555 (10.8%)	130 of 555 (23.4%)	Not reported
140 mg LY450139- NT	92 of 556 (16.5%)	258 of 556 (46.4%)	Not reported
Placebo- (Delayed Start Period [DO])	7 of 34 (20.6%)	6 of 34 (17.6%)	Not reported
140 mg LY450139- DO	1 of 22 (4.5%)	0 of 22 (0%)	Not reported
Placebo-Safety Follow Up Period (SFU)	22 of 430 (5.1%)	0 of 430 (0%)	Not reported
140 mg LY450139 - SFU	20 of 312 (6.4%)	0 of 312 (0%)	Not reported

Limitations and caveats (from the sponsor): All dosing for 4-week post-study drug cessation timeframe outcome measures stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening for LY450139 participants. No assessments made during 32-week follow up.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26402769Liu-Seifert H, Siemers E, Price K, Han B, Selzler KJ, Henley D, Sundell K, Aisen P, Cummings J, Raskin J, Mohs R; Alzheimer's Disease Neuroimaging Initiative. Cognitive Impairment Precedes and Predicts Functional Impairment in Mild Alzheimer's Disease. J Alzheimers Dis. 2015;47(1):205-14. doi: 10.3233/JAD-142508.
Derived from this study: PubMed 26120369Henley DB, Dowsett SA, Chen YF, Liu-Seifert H, Grill JD, Doody RS, Aisen P, Raman R, Miller DS, Hake AM, Cummings J. Alzheimer's disease progression by geographical region in a clinical trial setting. Alzheimers Res Ther. 2015 Jun 25;7(1):43. doi: 10.1186/s13195-015-0127-0. eCollection 2015.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559 Mon - Fri 9 AM - 5 PM eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

91 sites in 18 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LY450139 in people with Alzheimer's Disease, run by Eli Lilly and Company at 91 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States, Japan, Canada, Germany, Ukraine and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog11) at 76 Weeks (time frame: Baseline (randomization), 76 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00762411, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2015.