A Study of LY2886721 in Healthy Participants and Participants Diagnosed With Alzheimer's Disease
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01807026 |
|
Recruitment Status :
Completed
First Posted : March 8, 2013
Last Update Posted : June 3, 2013
|
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
| 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 |
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 ]
- Pharmacokinetics: Maximum Concentration (Cmax) of Plasma LY2886721 [ Time Frame: Predose up to 96 hours after administration of study drug ]
- 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 ]
- Pharmacokinetics: Maximum Concentration (Cmax) of CSF LY2886721 [ Time Frame: Predose up to 36 hours after administration of study drug ]
- Pharmacodynamics (PD): Cnadir of Plasma Amyloid β (Aβ)1-40 [ Time Frame: Predose up to 96 hours after administration of study drug ]
- PD: Cnadir of CSF Aβ 1-40 [ Time Frame: Predose up to 36 hours after administration of study drug ]
Secondary Outcome Measures :
- Cohort C: Mean QTcF Value at Cmax [ Time Frame: Predose up to 48 hours after administration of study drug ]
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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:
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| 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 Key Record Dates |
| 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 |