Alzheimer's DiseasePhase 1NCT01193608

Study Evaluating The Safety Of AAB-003 (PF-05236812) In Subjects With Alzheimer's Disease

A Phase 1 study testing AAB-003 (PF-05236812) in people with Alzheimer's Disease, run by Pfizer at 29 sites in 2 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

This is a study to evaluate the safety of multiple doses of AAB-003 (PF-05236812) in patients with mild to moderate Alzheimer's Disease. Patients will receive either AAB-003 (PF-05236812) or placebo. Each patient's participation will last approximately 41 weeks. Read more about this study

Who is it for?: Ages 50 to 89 years
Conditions the study is for: Alzheimer's Disease
What is being tested?: AAB-003 (PF-05236812)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 88 participants
Where: 29 sitesin 2 countries
Study dates: Sep 2010to Oct 2013
Phase: Phase 1
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 50 to 89 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of probable Alzheimer's Disease with MMSE score of 16-26, and brain MRI consistent with the diagnosis of Alzheimer's Disease
Concurrent use of cholinesterase inhibitor or memantine allowed, if stable.
Caregiver will participate and be able to attend clinic visits with patient

Who cannot join

Significant neurological disease other than Alzheimer's Disease
Major psychiatric disorder
Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal objects in the body)
Women of childbearing potential

Trial locations and contacts

29 sites in 2 countries.

Country

City, postcode or hospital

29 sites in 2 countries

United States23 sites

Atlanta Center for Medical Research
Atlanta, Georgia, 30308
Foers Medical Arts Pharmacy
Bethesda, Maryland, 20814
Millennium Psychiatric Associates, LLC
Creve Coeur, Missouri, 63141
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, 07724
Pharmacare USA
Edison, New Jersey, 08837
Early Phase Investigational Center
Escondido, California, 92025
Synergy Clinical Research Center of Escondido
Escondido, California, 92025
Brentwood Behavioral Healthcare
Flowood, Mississippi, 39232
Marty's Pharmacy
Flowood, Mississippi, 39232
Precise Research Centers
Flowood, Mississippi, 39232
MD Clinical
Hallandale, Florida, 33009
Borgess Medical Center
Kalamazoo, Michigan, 49048
Borgess Research Institute
Kalamazoo, Michigan, 49048
KNI/Southwest Michigan Imaging Center, LLC
Kalamazoo, Michigan, 49048
Central Jersey Radiology
Oakhurst, New Jersey, 07755
Franck's Pharmacy
Ocala, Florida, 34471
Munroe Regional Medical Center
Ocala, Florida, 34471
Renstar Medical Research
Ocala, Florida, 34471
Advanced Imaging of Ocala
Ocala, Florida, 34481
Belmont Center for Comprehensive Treatment
Philadelphia, Pennsylvania, 19131-1689
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
CBH Health, LLC
Rockville, Maryland, 20850
DePaul Health Center
St Louis, Missouri, 63044

Other trials in United States

South Korea6 sites

Inha University Hospital, Department of Neurology
Incheon
Seoul National University Bundang Hospital, Department of Neurology
Seongnam-si, Gyeonggi-do, 463-707
Samsung Medical Center, Department of Neurology
Seoul, 135-710
Korea University Anam Hospital
Seoul, 136-705
ASAN Medical Center
Seoul, 138-736
Konkuk University Medical Center, Department of Neurology
Seoul, 143-914

Other trials in South Korea

About this study

Official title: A Phase 1, Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptive, Multiple Ascending Dose Study Of The Safety, Tolerability And Pharmacokinetics Of Aab-003 (Pf-05236812) In Subjects With Mild To Moderate Alzheimer's Disease

Conditions: Alzheimer's Disease
Being tested: AAB-003 (PF-05236812), Placebo
Keywords: Randomized, Safety Study, Adaptive, Double Blind
Medical subject headings: Alzheimer Disease

What participants receive

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

AAB-003 (PF-05236812)Drug
0.5 mg/kg AAB-003, IV
AAB-003 (PF-05236812)Drug
1 mg/kg AAB-003, IV
AAB-003 (PF-05236812)Drug
2 mg/kg AAB-003, IV
AAB-003 (PF-05236812)Drug
4 mg/kg AAB-003, IV
AAB-003 (PF-05236812)Drug
8 mg/kg AAB-003, IV
PlaceboOther
Placebo, IV

Study groups in NCT01193608
Study group	Role	What they receive
0.5 mg/kg AAB-003	Experimental	Not described Receives: Drug: AAB-003 (PF-05236812)
1 mg/kg AAB-003	Experimental	Not described Receives: Drug: AAB-003 (PF-05236812)
2 mg/kg AAB-003	Experimental	Not described Receives: Drug: AAB-003 (PF-05236812)
4 mg/kg AAB-003	Experimental	Not described Receives: Drug: AAB-003 (PF-05236812)
8 mg/kg AAB-003	Experimental	Not described Receives: Drug: AAB-003 (PF-05236812)
Placebo	Placebo comparator	Not described Receives: Other: Placebo

What is being measured

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

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Measured: Baseline up to 39 Weeks and at Early Withdrawal
Number of Participants With Laboratory Abnormalities
Measured: Baseline up to 39 Weeks and at Early Withdrawal
Number of Participants With Vital Signs of Potential Clinical Concern
Criteria for potential clinical concern in vital signs included: supine/sitting pulse rate of less than (<) 40 or more than (>) 120 beats per minute (bpm), and standing pulse rate of <40 or >140 bpm; systolic blood pressure (SBP) of more than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in same posture and <90 mm Hg; diastolic blood pressure (DBP) >=20 mm Hg change from baseline in same posture and <50 mm Hg. Only supine vital signs were planned for this study. Unplanned sitting vital signs were collected only in the 8/mg and placebo groups and also reported.
Measured: Baseline up to 39 Weeks and at Early Withdrawal
Number of Participants With Abnormal Physical Examination Findings
Measured: Baseline up to 39 Weeks and at Early Withdrawal
Number of Participants With Abnormal Neurological Examination Findings
The neurological examination was done to the extent needed to assess the participant for any potential changes in neurological status, as determined by the investigator. The minimum items assessed were level of consciousness, speech, cranial nerves, motor, sensory, coordination, gait, and tendon reflexes.
Measured: Screening, Day 1 (Baseline) and Weeks 1,6,13,19,26,32, and 39, and at Early Withdrawal
Maximum Observed Serum Concentration (Cmax) for AAB-003 at Day 1
Measured: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Maximum Observed Serum Concentration (Cmax) for AAB-003 at at Week 26
Measured: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.
Average Concentration (Cavg) for AAB-003 in Serum at Day 1
Measured: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Average Concentration (Cavg) for AAB-003 in Serum at Week 26
Measured: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.
Time to Reach Maximum Observed Serum Concentration (Tmax) for AAB-003 at Day 1
Measured: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Time to Reach Maximum Observed Serum Concentration (Tmax) for AAB-003 at Week 26
Measured: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for AAB-003 in Serum at Day 1
Measured: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for AAB-003 in Serum at Day 1
Measured: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for AAB-003 in Serum at Day 1
Measured: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for AAB-003 in Serum at Week 26
Measured: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.
Systemic Clearance (CL) for AAB-003 in Serum at Day 1
Measured: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Systemic Clearance (CL) for AAB-003 in Serum at Week 26
Measured: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.
Volume of Distribution at Steady State (Vss) for AAB-003 in Serum at Day 1
Measured: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Volume of Distribution at Steady State (Vss) for AAB-003 in Serum at Week 26
Measured: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.
Serum Decay Half-Life (t1/2) for AAB-003 at Day 1
Measured: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Serum Decay Half-Life (t1/2) for AAB-003 at Week 26
Measured: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS assessed whether the participant experienced the following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has participant engaged in non-suicidal self-injurious behavior").
Measured: Baseline up to Week 39 or Early Withdrawal
Number of Participants With New Occurrence of Brain Magnetic Resonance Imaging (MRI) Finding
Brain MRIs were collected during the course of study to assess for any potential drug-related changes that might have constituted a safety concern for study participants. Findings suggestive of either vasogenic edema (VE) or intracranial hemorrhage represented adverse events of special circumstance and were to be reported immediately.
Measured: Baseline up to Week 32.
Number of Participants With Vasogenic Edema of All Severity After Each Infusion Visit
VE of the brain, identified via MRI, was identified as an adverse event of special circumstance.
Measured: Day 1, Week 13, and Week 26
Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarization Criteria
Criteria for ECG values of potential clinical concern are: interval between the start of the ECG P wave and the start of the QRS complex corresponding to the time between onset of atrial depolarization and onset of ventricular depolarization (PR): >= 300 milliseconds (msec), and >=25% increase when baseline >=200 msec/ >=50% increase when baseline less than or equal to (<=) 200 msec; time from ECG Q wave to the end of S wave corresponding to ventricular depolarization (QRS): >=200 msec, and >=25% increase when baseline >100 msec/ >=50% increase when baseline <=100 msec; QTc using Fridericia's formula (QTcF) interval: 450 to <480 msec, >=480 msec; QTcF change from baseline: 30 to <60 msec, and >=60 msec.
Measured: Baseline, Weeks 1,13,16,26,39 or Early Withdrawal

Timeline

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

Sep 2010Oct 2013

First posted2 Sep 2010 (estimated)
Study startSep 2010
Primary completionOct 2013
Study completionOct 2013

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 (1)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 PfizerThe 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 1
Primary purpose: Treatment
Allocation: Randomised
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01193608
Sponsor's protocol ID: B2601001
Other IDs: 3245K1-1000
Status last verified: Jan 2017
First submitted: 19 Aug 2010
Last updated: 23 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Delnomdedieu M, Duvvuri S, Li DJ, Atassi N, Lu M, Brashear HR, Liu E, Ness S, Kupiec JW. First-In-Human safety and long-term exposure data for AAB-003 (PF-05236812) and biomarkers after intravenous infusions of escalating doses in patients with mild to moderate Alzheimer's disease. Alzheimers Res Ther. 2016 Mar 1;8(1):12. doi: 10.1186/s13195-016-0177-y.
PubMed 26925577

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 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptive, Multiple Ascending Dose Study Of The Safety, Tolerability And Pharmacokinetics Of Aab-003 (Pf-05236812) In Subjects With Mild To Moderate Alzheimer's Disease
ClinicalTrials.gov ID: NCT01193608
Acronym / sponsor ID: B2601001
Conditions: Alzheimer's Disease
Keywords: Randomized, Safety Study, Adaptive, Double Blind
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study start: Sep 2010
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 2 Sep 2010 (estimated)
Results: Posted 23 Feb 2017

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
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
0.5 mg/kg AAB-003	Experimental	Drug: AAB-003 (PF-05236812)
1 mg/kg AAB-003	Experimental	Drug: AAB-003 (PF-05236812)
2 mg/kg AAB-003	Experimental	Drug: AAB-003 (PF-05236812)
4 mg/kg AAB-003	Experimental	Drug: AAB-003 (PF-05236812)
8 mg/kg AAB-003	Experimental	Drug: AAB-003 (PF-05236812)
Placebo	Placebo comparator	Other: Placebo

Who may qualify

Ages: 50 to 89 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosis of probable Alzheimer's Disease with MMSE score of 16-26, and brain MRI consistent with the diagnosis of Alzheimer's Disease
Concurrent use of cholinesterase inhibitor or memantine allowed, if stable.
Caregiver will participate and be able to attend clinic visits with patient

Key exclusion criteria (4 listed)

Significant neurological disease other than Alzheimer's Disease
Major psychiatric disorder
Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal objects in the body)
Women of childbearing potential

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
AAB-003 (PF-05236812)0.5 mg/kg AAB-003, IV	Drug	0.5 mg/kg AAB-003
AAB-003 (PF-05236812)1 mg/kg AAB-003, IV	Drug	1 mg/kg AAB-003
AAB-003 (PF-05236812)2 mg/kg AAB-003, IV	Drug	2 mg/kg AAB-003
AAB-003 (PF-05236812)4 mg/kg AAB-003, IV	Drug	4 mg/kg AAB-003
AAB-003 (PF-05236812)8 mg/kg AAB-003, IV	Drug	8 mg/kg AAB-003
PlaceboPlacebo, IV	Other	Placebo

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline up to 39 Weeks and at Early Withdrawal
Number of Participants With Laboratory Abnormalities
Time frame: Baseline up to 39 Weeks and at Early Withdrawal
Number of Participants With Vital Signs of Potential Clinical Concern
Time frame: Baseline up to 39 Weeks and at Early Withdrawal
Criteria for potential clinical concern in vital signs included: supine/sitting pulse rate of less than (<) 40 or more than (>) 120 beats per minute (bpm), and standing pulse rate of <40 or >140 bpm; systolic blood pressure (SBP) of more than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in same posture and <90 mm Hg; diastolic blood pressure (DBP) >=20 mm Hg change from baseline in same posture and <50 mm Hg. Only supine vital signs were planned for this study. Unplanned sitting vital signs were collected only in the 8/mg and placebo groups and also reported.
Number of Participants With Abnormal Physical Examination Findings
Time frame: Baseline up to 39 Weeks and at Early Withdrawal
Number of Participants With Abnormal Neurological Examination Findings
Time frame: Screening, Day 1 (Baseline) and Weeks 1,6,13,19,26,32, and 39, and at Early Withdrawal
The neurological examination was done to the extent needed to assess the participant for any potential changes in neurological status, as determined by the investigator. The minimum items assessed were level of consciousness, speech, cranial nerves, motor, sensory, coordination, gait, and tendon reflexes.
Maximum Observed Serum Concentration (Cmax) for AAB-003 at Day 1
Time frame: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Maximum Observed Serum Concentration (Cmax) for AAB-003 at at Week 26
Time frame: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.
Average Concentration (Cavg) for AAB-003 in Serum at Day 1
Time frame: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Average Concentration (Cavg) for AAB-003 in Serum at Week 26
Time frame: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.
Time to Reach Maximum Observed Serum Concentration (Tmax) for AAB-003 at Day 1
Time frame: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Time to Reach Maximum Observed Serum Concentration (Tmax) for AAB-003 at Week 26
Time frame: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for AAB-003 in Serum at Day 1
Time frame: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for AAB-003 in Serum at Day 1
Time frame: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for AAB-003 in Serum at Day 1
Time frame: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for AAB-003 in Serum at Week 26
Time frame: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.
Systemic Clearance (CL) for AAB-003 in Serum at Day 1
Time frame: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Systemic Clearance (CL) for AAB-003 in Serum at Week 26
Time frame: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.
Volume of Distribution at Steady State (Vss) for AAB-003 in Serum at Day 1
Time frame: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Volume of Distribution at Steady State (Vss) for AAB-003 in Serum at Week 26
Time frame: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.
Serum Decay Half-Life (t1/2) for AAB-003 at Day 1
Time frame: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.
Serum Decay Half-Life (t1/2) for AAB-003 at Week 26
Time frame: Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline up to Week 39 or Early Withdrawal
The C-SSRS assessed whether the participant experienced the following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has participant engaged in non-suicidal self-injurious behavior").
Number of Participants With New Occurrence of Brain Magnetic Resonance Imaging (MRI) Finding
Time frame: Baseline up to Week 32.
Brain MRIs were collected during the course of study to assess for any potential drug-related changes that might have constituted a safety concern for study participants. Findings suggestive of either vasogenic edema (VE) or intracranial hemorrhage represented adverse events of special circumstance and were to be reported immediately.
Number of Participants With Vasogenic Edema of All Severity After Each Infusion Visit
Time frame: Day 1, Week 13, and Week 26
VE of the brain, identified via MRI, was identified as an adverse event of special circumstance.
Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarization Criteria
Time frame: Baseline, Weeks 1,13,16,26,39 or Early Withdrawal
Criteria for ECG values of potential clinical concern are: interval between the start of the ECG P wave and the start of the QRS complex corresponding to the time between onset of atrial depolarization and onset of ventricular depolarization (PR): >= 300 milliseconds (msec), and >=25% increase when baseline >=200 msec/ >=50% increase when baseline less than or equal to (<=) 200 msec; time from ECG Q wave to the end of S wave corresponding to ventricular depolarization (QRS): >=200 msec, and >=25% increase when baseline >100 msec/ >=50% increase when baseline <=100 msec; QTc using Fridericia's formula (QTcF) interval: 450 to <480 msec, >=480 msec; QTcF change from baseline: 30 to <60 msec, and >=60 msec.

Results and safety

Results posted to the registry on 23 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AAB-003 0.5 mg/kg	6	6
AAB-003 1 mg/kg	6	4
AAB-003 2 mg/kg	16	14
AAB-003 4 mg/kg	17	14
AAB-003 8 mg/kg	24	19
Placebo	19	17

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Time frame: Baseline up to 39 Weeks and at Early Withdrawal. Number. Unit: Participants

Measure	AAB-003 0.5 mg/kg n = 6	AAB-003 1 mg/kg n = 6	AAB-003 2 mg/kg n = 16	AAB-003 4 mg/kg n = 17	AAB-003 8 mg/kg n = 24	Placebo n = 19
Participants with Adverse Events (AEs)	5	3	10	8	16	12
Participants with Serious Adverse Events (SAEs)	1	1	1	0	5	0
Participants Discontinued due to AEs	0	0	0	0	3	1

Population analysed: Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions). A TEAE was defined as an untoward medical occurrence reported by the participant or investigator following administration of at least one dose of AAB-003.

Primary outcome: Number of Participants With Laboratory Abnormalities

Time frame: Baseline up to 39 Weeks and at Early Withdrawal. Number. Unit: Participants

Measure	AAB-003 0.5 mg/kg n = 6	AAB-003 1 mg/kg n = 6	AAB-003 2 mg/kg n = 16	AAB-003 4 mg/kg n = 17	AAB-003 8 mg/kg n = 24	Placebo n = 19
Value	3	3	11	10	12	13

Population analysed: Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions). Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy).

Primary outcome: Number of Participants With Vital Signs of Potential Clinical Concern

Time frame: Baseline up to 39 Weeks and at Early Withdrawal. Number. Unit: Participants

Measure	AAB-003 0.5 mg/kg n = 6	AAB-003 1 mg/kg n = 6	AAB-003 2 mg/kg n = 16	AAB-003 4 mg/kg n = 17	AAB-003 8 mg/kg n = 24	Placebo n = 19
Supine SBP <90 mm Hg	0	0	1	0	1	0
Maximum increase in supine SBP >=30 mm Hg	3	0	3	7	2	6
Maximum decrease in supine SBP >=30 mm Hg	0	0	5	0	4	8
Sitting SBP <90 mm Hg	NA	NA	NA	NA	0	0
Supine DBP <50 mm Hg	0	0	0	0	0	1
Maximum increase in supine DBP >=20 mm Hg	2	3	4	2	5	8
Maximum decrease in supine DBP >=20 mm Hg	1	0	4	1	4	8
Sitting DBP <50 mm Hg	NA	NA	NA	NA	0	0

Population analysed: Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions).

Primary outcome: Number of Participants With Abnormal Physical Examination Findings

Time frame: Baseline up to 39 Weeks and at Early Withdrawal. Number. Unit: Participants

Measure	AAB-003 0.5 mg/kg n = 6	AAB-003 1 mg/kg n = 6	AAB-003 2 mg/kg n = 16	AAB-003 4 mg/kg n = 17	AAB-003 8 mg/kg n = 24	Placebo n = 19
Value	2	4	1	5	9	9

Population analysed: Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions). A full physical examination consisted of abdomen, genitourinary, cardiovascular systems, lungs, lymph nodes, mouth, musculoskeletal, general, skin, extremities, head, ears, eyes, nose, throat and thyroid.

Adverse events

Time frame: Baseline up to 39 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AAB-003 0.5 mg/kg	1 of 6 (16.7%)	5 of 6 (83.3%)	Not reported
AAB-003 1 mg/kg	1 of 6 (16.7%)	3 of 6 (50%)	Not reported
AAB-003 2 mg/kg	1 of 16 (6.3%)	10 of 16 (62.5%)	Not reported
AAB-003 4 mg/kg	0 of 17 (0%)	8 of 17 (47.1%)	Not reported
AAB-003 8 mg/kg	5 of 24 (20.8%)	10 of 24 (41.7%)	Not reported
Placebo	0 of 19 (0%)	12 of 19 (63.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26925577Delnomdedieu M, Duvvuri S, Li DJ, Atassi N, Lu M, Brashear HR, Liu E, Ness S, Kupiec JW. First-In-Human safety and long-term exposure data for AAB-003 (PF-05236812) and biomarkers after intravenous infusions of escalating doses in patients with mild to moderate Alzheimer's disease. Alzheimers Res Ther. 2016 Mar 1;8(1):12. doi: 10.1186/s13195-016-0177-y.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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.

Pfizer CT.gov Call Center study director

Pfizer

29 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AAB-003 (PF-05236812) in people with Alzheimer's Disease, run by Pfizer at 29 sites in 2 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 3 inclusion and 4 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, South Korea. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 23 Feb 2017). 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?

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Baseline up to 39 Weeks and at Early Withdrawal). The study lists 25 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 NCT01193608, which also lists 1 linked publication.

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 23 Feb 2017.