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A Study of LY3372689 to Assess the Safety, Tolerability, and Efficacy in Participants 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: NCT05063539
Recruitment Status : Active, not recruiting
First Posted : October 1, 2021
Last Update Posted : March 24, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The purpose of this study is to assess the safety, tolerability and effect of study drug LY3372689 in participants with early symptomatic Alzheimer's Disease

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: LY3372689 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Based on a common closed study design. Participants final endpoint time will be between 76-124 weeks.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of Safety, Tolerability, and Efficacy of LY3372689 in Early Symptomatic Alzheimer's Disease
Actual Study Start Date : September 16, 2021
Estimated Primary Completion Date : May 16, 2024
Estimated Study Completion Date : June 13, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3372689 High Dose
LY3372689 given orally
 Drug: LY3372689
given orally
Experimental: LY3372689 Low Dose
LY3372689 given orally
 Drug: LY3372689
given orally
Placebo Comparator: Placebo
Placebo given orally
 Drug: Placebo
given orally


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline to End Time Point in Integrated Alzheimer's Disease Rating Scale (iADRS) [ Time Frame: Baseline, 76 to 124 Weeks ]
    Change from Baseline to End Time Point in iADRS will be measured in participants with early symptomatic Alzheimer's Disease (AD) with demonstrated presence of moderate levels of tau pathology


Secondary Outcome Measures :
  1. Change from Baseline to End Time Point in iADRS [ Time Frame: Baseline, 76 to 124 Weeks ]
    Change from baseline to end point time in iADRS will be measured in the full study population (moderate + high levels of tau pathology) with early symptomatic AD

  2. Change From Baseline to End Time Point in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) [ Time Frame: Baseline, 76 to 124 Weeks ]
    Change From Baseline to End Time Point in CDR-SB

  3. Change from Baseline to End Time Point in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) [ Time Frame: Baseline, 76 to 124 Weeks ]
    Change from Baseline to End Time Point in ADAS-Cog13

  4. Change from Baseline to End Time Point in Alzheimer's Disease Cooperative Study Instrumental Activities of Daily Living Inventory (ADCS-iADL) [ Time Frame: Baseline, 76 to 124 Weeks ]
    Change from Baseline to End Time Point in ADCS-iADL

  5. Change from Baseline to End Time Point in Mini Mental State Examination (MMSE) [ Time Frame: Baseline, 76 to 124 Weeks ]
    Change from Baseline to End Time Point in MMSE

  6. Change from Baseline to End Time Point in Brain Tau Deposition as Measured by Flortaucipir F18 PET scan [ Time Frame: Baseline, 76 to 124 Weeks ]
    Change from Baseline to End Time Point in Brain Tau Deposition as Measured by Flortaucipir F18 PET scan

  7. Change from Baseline to End Time Point in Volumetric Magnetic Resonance Imaging (vMRI) Measures [ Time Frame: Baseline, 76 to 124 Weeks ]
    Change from Baseline to End Time Point in Volumetric MRI Measures

  8. Pharmacokinetics (PK) Plasma Concentration of LY3372689 [ Time Frame: Up to 124 Weeks ]
    PK Plasma Concentration of LY3372689


Eligibility Criteria
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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:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months
  • MMSE score of 22 to 30 (inclusive) at baseline
  • CDR global score of 0.5 to 1.0 (inclusive), with a memory box score ≥0.5.
  • Meet 18F flortaucipir positron emission tomography (PET) scan (central analysis) criteria
  • Have a study partner who will provide written informed consent to participate

Exclusion Criteria:

  • Contraindication to MRI or PET scans
  • Have known allergies to LY3372689, related compounds, or any components of the formulations
Contacts and Locations
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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): NCT05063539


Locations
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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
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05063539    
Other Study ID Numbers: 18094
I9X-MC-MTAE ( Other Identifier: Eli Lilly and Company )
2021-000170-29 ( EudraCT Number )
First Posted: October 1, 2021    Key Record Dates
Last Update Posted: March 24, 2023
Last Verified: March 15, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://www.vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Dementia
Mild Cognitive Impairment
Prodromal Alzheimer's Disease
 Tauopathy
Tau
OGA Inhibitor
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