Alzheimer DiseasePhase 1NCT01807026

A Study of LY2886721 in Healthy Participants and Participants Diagnosed With Alzheimer's Disease

A Phase 1 study testing LY2886721 in people with Alzheimer Disease and Healthy Volunteers, run by Eli Lilly and Company at 1 site in United States.

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 study is being done for the following reasons: To determine the safety of LY2886721 and any side effects that may be associated with it and to see how much of the study drug is in the blood and the cerebrospinal fluid (CSF) when one dose is given to healthy participants and participants diagnosed with Alzheimer's… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Alzheimer Disease, Healthy Volunteers
What is being tested?: LY2886721
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 1 siteUnited States
Study dates: Mar 2013to May 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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy participants have a body mass index (BMI) of 19 to 32 kilograms per square meter (kg/m^2), inclusive, at screening. There are no restrictions on BMI in participants diagnosed with Alzheimer's disease.
Healthy participants should not be taking any concomitant medications. For participants with Alzheimer's disease, concomitant medications will be determined by the investigator in consultation with the Lilly clinical pharmacologist on an individual basis.
Cohort A:
Participants are defined as otherwise healthy males or females as determined by medical history and physical examination, and a diagnosis of Alzheimer's disease and must be at least 45 years of age.
Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's disease, as determined by a clinician approved by the sponsor or designee.
Mini Mental State Examination (MMSE) score of 16 through 28 at screening.

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Modified Hachinski Ischemia Scale (MHIS) score of <4.
Capable of understanding and signing their own informed consent, in the opinion of the investigator, or if the participant has a Legally Authorized Representative (LAR), then the LAR must be capable of understanding and signing the assent form, and the participant may or may not sign the informed consent, as to be determined by the investigator.
If receiving concurrent treatment with an acetylcholinesterase inhibitor (AChEI) and/or memantine, the participant has been on a stable dose for at least 4 weeks before Day 1. Dosing must remain stable throughout the study. Note: If a participant has recently stopped ACHEIs and/or memantine, he or she must have discontinued treatment for at least 4 weeks before Day 1.

Who cannot join

Have an abnormality in the 12-lead electrocardiogram (ECG).
Have abnormal blood pressure.
Have abnormal thyroid function as reflected by thyroid stimulating hormone (TSH) values outside of the normal range.
Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies.
Show evidence of hepatitis C and/or positive hepatitis C antibody.
Have had multiple episodes of head trauma, or have a history within the last 5 years of a serious infectious disease affecting the brain.

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Have chronic hepatic disease.
Have evidence or history of significant active bleeding or a coagulation disorder.
Cohort A: have any neurological disorders other than Alzheimer's disease.
For healthy participants (Cohorts B and C) only: Use or intend to use over the- counter or prescription medication, including herbal medications within 14 days prior to dosing or during the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Salt Lake City, Utah

Other trials in United States

About this study

Official title: A Safety, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects and Patients Diagnosed With Alzheimer's Disease

This study is being done for the following reasons:

To determine the safety of LY2886721 and any side effects that may be associated with it and to see how much of the study drug is in the blood and the cerebrospinal fluid (CSF) when one dose is given to healthy participants and participants diagnosed with Alzheimer's disease. It will also look at how safe and tolerable the study drug is when given to healthy participants in higher doses.

This research study is being conducted in three groups, referred to as Groups (Cohorts) A, B, or C.

Group A will enroll participants with Alzheimer's disease while Groups B and C will enroll healthy participants.

For Group A or B, participation in this research study could last up to 34 days. For Group C, participation could last up to 60 days.

Conditions: Alzheimer Disease, Healthy Volunteers
Being tested: LY2886721, Placebo
Medical subject headings: Alzheimer Disease

What participants receive

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

LY2886721Drug
PlaceboDrug

Study groups in NCT01807026
Study group	Role	What they receive
Cohort A: 70 mg LY2886721	Experimental	Participants with Alzheimer's disease received a single, 70-milligrams (mg) (1 capsule), oral dose of LY2886721. Receives: Drug: LY2886721
Cohort A: Placebo	Placebo comparator	Participants with Alzheimer's disease received a single, oral dose of LY2886721-matching placebo (1 capsule). Receives: Drug: Placebo
Cohort B: 70 mg LY2886721	Experimental	Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721. Receives: Drug: LY2886721
Cohort B: Placebo	Placebo comparator	Healthy participants received a single, oral dose of LY2886721-matching placebo (1 capsule). Receives: Drug: Placebo
Cohort C: 280 mg LY2886721	Experimental	Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721. Receives: Drug: LY2886721
Cohort C: Placebo	Placebo comparator	Healthy participants received a single, oral dose of LY2886721-matching placebo (4 capsules). Receives: Drug: Placebo

What is being measured

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

Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Plasma LY2886721
AUC0-∞ following administration of a single dose of 70 or 280 mg LY2886721.
Measured: Predose through 96 hours after administration of study drug
Pharmacokinetics: Maximum Concentration (Cmax) of Plasma LY2886721
Cmax following administration of a single dose of 70 or 280 mg LY2886721.
Measured: Predose through 96 hours after administration of study drug
Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Cerebrospinal Fluid (CSF) LY2886721
AUC0-∞ following administration of a single dose of 70 mg LY2886721.
Measured: Predose through 36 hours after administration of study drug
Pharmacokinetics: Maximum Concentration (Cmax) of CSF LY2886721
Cmax following administration of a single dose of 70 mg LY2886721.
Measured: Predose through 36 hours after administration of study drug
Pharmacodynamics (PD): Cnadir of Plasma Amyloid β (Aβ)1-40
Plasma concentration of Aβ1-40 was summarized based on lowest observed concentration (Cnadir).
Measured: Predose, up to 96 hours after administration of study drug
PD: Cnadir of CSF Aβ 1-40
Plasma concentration of Aβ1-40 was summarized based on Cnadir following administration of a single dose of 70 mg LY2886721 or a single dose of LY2886721-matching placebo.
Measured: Predose up to 36 hours after administration of study drug

Secondary outcomes (1)

Cohort C: Mean QTcF Value at Cmax
The mean QTcF value at Cmax for participants administered a single dose of 280 mg LY2886721 was reported. The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. Time matched mean change from baseline in QTcF = time matched plasma concentration + participant + random error.
Measured: Predose up to 48 hours after administration of study drug

Timeline

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

Mar 2013May 2013

First posted8 Mar 2013 (estimated)
Study startMar 2013
Primary completionMay 2013
Study completionMay 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.
Other trials for Alzheimer 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 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01807026
Sponsor's protocol ID: 15107
Other IDs: I4O-EW-BACX
Status last verified: May 2019
First submitted: 6 Mar 2013
Last updated: 19 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Safety, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects and Patients Diagnosed With Alzheimer's Disease
ClinicalTrials.gov ID: NCT01807026
Acronym / sponsor ID: 15107
Conditions: Alzheimer Disease, Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Mar 2013
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 8 Mar 2013 (estimated)
Results: Posted 19 Jul 2019

Clinical summary

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

This study is being done for the following reasons:

This research study is being conducted in three groups, referred to as Groups (Cohorts) A, B, or C.

Group A will enroll participants with Alzheimer's disease while Groups B and C will enroll healthy participants.

For Group A or B, participation in this research study could last up to 34 days. For Group C, participation could last up to 60 days.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Cohort A: 70 mg LY2886721	Experimental	Drug: LY2886721Participants with Alzheimer's disease received a single, 70-milligrams (mg) (1 capsule), oral dose of LY2886721.
Cohort A: Placebo	Placebo comparator	Drug: PlaceboParticipants with Alzheimer's disease received a single, oral dose of LY2886721-matching placebo (1 capsule).
Cohort B: 70 mg LY2886721	Experimental	Drug: LY2886721Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721.
Cohort B: Placebo	Placebo comparator	Drug: PlaceboHealthy participants received a single, oral dose of LY2886721-matching placebo (1 capsule).
Cohort C: 280 mg LY2886721	Experimental	Drug: LY2886721Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721.
Cohort C: Placebo	Placebo comparator	Drug: PlaceboHealthy participants received a single, oral dose of LY2886721-matching placebo (4 capsules).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Healthy participants have a body mass index (BMI) of 19 to 32 kilograms per square meter (kg/m^2), inclusive, at screening. There are no restrictions on BMI in participants diagnosed with Alzheimer's disease.
Healthy participants should not be taking any concomitant medications. For participants with Alzheimer's disease, concomitant medications will be determined by the investigator in consultation with the Lilly clinical pharmacologist on an individual basis.
Participants are defined as otherwise healthy males or females as determined by medical history and physical examination, and a diagnosis of Alzheimer's disease and must be at least 45 years of age.
Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's disease, as determined by a clinician approved by the sponsor or designee.
Mini Mental State Examination (MMSE) score of 16 through 28 at screening.

Key exclusion criteria (10 listed)

Have an abnormality in the 12-lead electrocardiogram (ECG).
Have abnormal blood pressure.
Have abnormal thyroid function as reflected by thyroid stimulating hormone (TSH) values outside of the normal range.
Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies.
Show evidence of hepatitis C and/or positive hepatitis C antibody.

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
LY2886721	Drug	Cohort A: 70 mg LY2886721, Cohort B: 70 mg LY2886721, Cohort C: 280 mg LY2886721
Placebo	Drug	Cohort A: Placebo, Cohort B: Placebo, Cohort C: Placebo

Primary outcome

Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Plasma LY2886721
Time frame: Predose through 96 hours after administration of study drug
AUC0-∞ following administration of a single dose of 70 or 280 mg LY2886721.
Pharmacokinetics: Maximum Concentration (Cmax) of Plasma LY2886721
Time frame: Predose through 96 hours after administration of study drug
Cmax following administration of a single dose of 70 or 280 mg LY2886721.
Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Cerebrospinal Fluid (CSF) LY2886721
Time frame: Predose through 36 hours after administration of study drug
AUC0-∞ following administration of a single dose of 70 mg LY2886721.
Pharmacokinetics: Maximum Concentration (Cmax) of CSF LY2886721
Time frame: Predose through 36 hours after administration of study drug
Cmax following administration of a single dose of 70 mg LY2886721.
Pharmacodynamics (PD): Cnadir of Plasma Amyloid β (Aβ)1-40
Time frame: Predose, up to 96 hours after administration of study drug
Plasma concentration of Aβ1-40 was summarized based on lowest observed concentration (Cnadir).
PD: Cnadir of CSF Aβ 1-40
Time frame: Predose up to 36 hours after administration of study drug
Plasma concentration of Aβ1-40 was summarized based on Cnadir following administration of a single dose of 70 mg LY2886721 or a single dose of LY2886721-matching placebo.

1 secondary outcome

Cohort C: Mean QTcF Value at Cmax
Time frame: Predose up to 48 hours after administration of study drug

Results and safety

Results posted to the registry on 19 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A: 70 mg LY2886721	10	10
Cohort A: Placebo	2	2
Cohort B: 70 mg LY2886721	10	10
Cohort B: Placebo	2	2
Cohort C: 280 mg LY2886721	9	9
Cohort C: Placebo	3	3

Primary outcome: Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Plasma LY2886721

Time frame: Predose through 96 hours after administration of study drug. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms*hours/milliliter (ng*h/mL)

Measure	Cohort A: 70 mg LY2886721 n = 10	Cohort B: 70 mg LY2886721 n = 10	Cohort C: 280 mg LY2886721 n = 9
Value	2800 (25)	2580 (20)	10500 (22)

Population analysed: Participants who received at least one dose of LY2886721 and with evaluable plasma LY2886721-concentration data.

Primary outcome: Pharmacokinetics: Maximum Concentration (Cmax) of Plasma LY2886721

Time frame: Predose through 96 hours after administration of study drug. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms/milliliter (ng/mL)

Measure	Cohort A: 70 mg LY2886721 n = 10	Cohort B: 70 mg LY2886721 n = 10	Cohort C: 280 mg LY2886721 n = 9
Value	183 (41)	180 (17)	888 (11)

Population analysed: Participants who received at least one dose of LY2886721 and with evaluable plasma LY2886721-concentration data.

Primary outcome: Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Cerebrospinal Fluid (CSF) LY2886721

Time frame: Predose through 36 hours after administration of study drug. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Cohort A: 70 mg LY2886721 n = 10	Cohort B: 70 mg LY2886721 n = 10
Value	458 (16)	410 (16)

Population analysed: Participants who received at least one dose of LY2886721 at the 70-mg dose level and with evaluable CSF LY2886721-concentration data.

Primary outcome: Pharmacokinetics: Maximum Concentration (Cmax) of CSF LY2886721

Time frame: Predose through 36 hours after administration of study drug. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Cohort A: 70 mg LY2886721 n = 10	Cohort B: 70 mg LY2886721 n = 10
Value	24.0 (18)	24.4 (19)

Population analysed: Participants who received at least one dose of LY2886721 at the 70-mg dose level and with evaluable CSF LY2886721-concentration data.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort A: 70 mg LY2886721	0 of 10 (0%)	4 of 10 (40%)	Not reported
Cohort A: Placebo	0 of 2 (0%)	1 of 2 (50%)	Not reported
Cohort B: 70 mg LY2886721	0 of 10 (0%)	8 of 10 (80%)	Not reported
Cohort B: Placebo	0 of 2 (0%)	0 of 2 (0%)	Not reported
Cohort C: 280 mg LY2886721	0 of 9 (0%)	1 of 9 (11.1%)	Not reported
Cohort C: Placebo	0 of 3 (0%)	0 of 3 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2886721 in people with Alzheimer Disease and Healthy Volunteers, run by Eli Lilly and Company at 1 site in United States.

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 9 inclusion and 10 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 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 19 Jul 2019). 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?

Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Plasma LY2886721 (time frame: Predose through 96 hours after administration of study drug). The study lists 6 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 NCT01807026.

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 19 Jul 2019.