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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
Results First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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 (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.


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

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Study Type : Interventional  (Clinical Trial)
Actual 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


Arm Intervention/treatment
Experimental: Cohort A: 70 mg LY2886721
Participants with Alzheimer's disease received a single, 70-milligrams (mg) (1 capsule), oral dose of LY2886721.
Drug: LY2886721
Placebo Comparator: Cohort A: Placebo
Participants with Alzheimer's disease received a single, oral dose of LY2886721-matching placebo (1 capsule).
Drug: Placebo
Experimental: Cohort B: 70 mg LY2886721
Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721.
Drug: LY2886721
Placebo Comparator: Cohort B: Placebo
Healthy participants received a single, oral dose of LY2886721-matching placebo (1 capsule).
Drug: Placebo
Experimental: Cohort C: 280 mg LY2886721
Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721.
Drug: LY2886721
Placebo Comparator: Cohort C: Placebo
Healthy participants received a single, oral dose of LY2886721-matching placebo (4 capsules).
Drug: Placebo



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.


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



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.


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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 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

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
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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
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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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01807026    
Other Study ID Numbers: 15107
I4O-EW-BACX ( Other Identifier: Eli Lilly and Company )
First Posted: March 8, 2013    Key Record Dates
Results First Posted: July 19, 2019
Last Update Posted: July 19, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders