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NCT Number: NCT01807026

A Study of LY2886721 in Healthy Participants and Participants 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 (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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY2886721

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Safety, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects and Patients Diagnosed With Alzheimer's Disease

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 8, 2013
Registry last updated
Jul 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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