A Study of LY2886721 in Healthy Participants and Participants Diagnosed With Alzheimer's Disease
| Status: | Completed |
|---|---|
| Conditions: | Alzheimer Disease, Healthy Studies |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/30/2013 |
| Start Date: | March 2013 |
| End Date: | May 2013 |
| Contact: | This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) or |
| Phone: | 1-317-615-4559 |
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 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.
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:
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