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

Study Description

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Brief 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 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.

Condition or disease	Intervention/treatment	Phase
Alzheimer Disease; Healthy Volunteers	Drug: LY2886721; Drug: Placebo	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	36 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Basic Science
Official Title:	A Safety, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects and Patients Diagnosed With Alzheimer's Disease
Study Start Date :	March 2013
Actual Primary Completion Date :	May 2013
Actual Study Completion Date :	May 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Cohort A - LY2886721; Alzheimer's disease (AD) participants will receive a 70 mg single oral dose of LY2886721.	Drug: LY2886721; Administered orally
Placebo Comparator: Cohort A - Placebo; AD participants will receive a single oral dose of placebo.	Drug: Placebo; Administered orally
Experimental: Cohort B - LY2886721; Healthy participants will receive a single 70 mg oral dose of LY2886721.	Drug: LY2886721; Administered orally
Placebo Comparator: Cohort B - Placebo; Healthy participants will receive a single oral dose of placebo.	Drug: Placebo; Administered orally
Experimental: Cohort C - LY2886721; Healthy participants will receive a single oral ascending dose of LY2886721 in at least 2 of 3 study periods.	Drug: LY2886721; Administered orally
Placebo Comparator: Cohort C - Placebo; Healthy participants will receive a single oral dose of placebo in up to 1 of 3 study periods.	Drug: Placebo; Administered orally

Outcome Measures

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Primary Outcome Measures :

1. Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Plasma LY2886721 [ Time Frame: Predose up to 96 hours after administration of study drug ]
2. Pharmacokinetics: Maximum Concentration (Cmax) of Plasma LY2886721 [ Time Frame: Predose up to 96 hours after administration of study drug ]
3. Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Cerebrospinal Fluid (CSF) LY2886721 [ Time Frame: Predose up to 36 hours after administration of study drug ]
4. Pharmacokinetics: Maximum Concentration (Cmax) of CSF LY2886721 [ Time Frame: Predose up to 36 hours after administration of study drug ]
5. Pharmacodynamics (PD): Cnadir of Plasma Amyloid β (Aβ)1-40 [ Time Frame: Predose up to 96 hours after administration of study drug ]
6. PD: Cnadir of CSF Aβ 1-40 [ Time Frame: Predose up to 36 hours after administration of study drug ]

Secondary Outcome Measures :

1. Cohort C: Mean QTcF Value at Cmax [ Time Frame: Predose up to 48 hours after administration of study drug ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• 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 AD
• Healthy participants should not be taking any concomitant medications. For participants with AD, 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, physical examination and a diagnosis of AD 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 AD; as determined by a clinician approved by the sponsor or designee
• Mini Mental State Examination (MMSE) score of 16 through 28 at screening
• 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, 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

Exclusion Criteria:

Contacts and Locations

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Locations

United States, Utah
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, United States

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:	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)	Eli Lilly and Company

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01807026 History of Changes
Other Study ID Numbers:	15107; I4O-EW-BACX ( Other Identifier: Eli Lilly and Company )
First Posted:	March 8, 2013
Last Update Posted:	June 3, 2013
Last Verified:	May 2013

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases	Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders