A Study of LY2886721 in Healthy Participants and Participants Diagnosed With Alzheimer's Disease - Full Text View

Purpose

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	Intervention	Phase
Alzheimer Disease Healthy Volunteers	Drug: LY2886721 Drug: Placebo	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Plasma LY2886721 [ Time Frame: Predose up to 96 hours after administration of study drug ] [ Designated as safety issue: No ]
Pharmacokinetics: Maximum Concentration (Cmax) of Plasma LY2886721 [ Time Frame: Predose up to 96 hours after administration of study drug ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Pharmacokinetics: Maximum Concentration (Cmax) of CSF LY2886721 [ Time Frame: Predose up to 36 hours after administration of study drug ] [ Designated as safety issue: No ]
Pharmacodynamics (PD): Cnadir of Plasma Amyloid β (Aβ)1-40 [ Time Frame: Predose up to 96 hours after administration of study drug ] [ Designated as safety issue: No ]
PD: Cnadir of CSF Aβ 1-40 [ Time Frame: Predose up to 36 hours after administration of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cohort C: Mean QTcF Value at Cmax [ Time Frame: Predose up to 48 hours after administration of study drug ] [ Designated as safety issue: No ]


Estimated Enrollment:	36
Study Start Date:	March 2013
Study Completion Date:	May 2013
Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01807026

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


Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01807026 History of Changes
Other Study ID Numbers:	15107 I4O-EW-BACX
Study First Received:	March 6, 2013
Last Updated:	May 31, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 27, 2016