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A Study of LY3372689 to Assess the Safety, Tolerability, and Efficacy in Participants With Alzheimer's Disease

Primary Purpose

Alzheimer Disease

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LY3372689
LY3372689
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Dementia, Mild Cognitive Impairment, Prodromal Alzheimer's Disease, Tauopathy, Tau, OGA Inhibitor

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hope Clinical Research, Inc.
  • Neuro-Pain Medical Center
  • Irvine Clinical Research Center
  • Sharp Mesa Vista Hospital
  • Institute for Neurodegenerative Disorders
  • JEM Research Institute
  • VIN-Julie Schwartzbard
  • Neurology Offices of South Florida
  • Neuropsychiatric Research Center of Southwest Florida
  • Charter Research
  • K2 Medical Research
  • ClinCloud - Viera
  • Merritt Island Medical Research, LLC
  • Visionary Investigators Network
  • VIN-Victor Faradji
  • Suncoast Clinical Research
  • Renstar Medical Research
  • IMIC, Inc.
  • VIN- Margarita Almeida El-Ramey
  • Brain Matters Research
  • Josephson Wallack Munshower Neurology, PC
  • Eastern Maine Medical Center
  • Boston Center for Memory
  • Donald S. Marks M.D., P.C.
  • MedVadis Research Corporation
  • Adams Clinical
  • The Cognitive and Research Center of New Jersey
  • Advanced Memory Research Institute of New Jersey
  • University at Buffalo - UBMD Neurology
  • NYU Langone Health
  • Abington Neurological Associates, Ltd.
  • Keystone Clinical Studies
  • Rhode Island Mood & Memory Research Institute
  • Kerwin Medical Center
  • The University of Texas Health Science Center at Houston
  • The Memory Clinic
  • Central Coast Neurosciences Research (Tumbi Umbi)
  • St Vincent's Hospital Sydney
  • HammondCare Greenwich Hospital
  • Hornsby Ku-Ring-Gai Hospital
  • KARA Institute for Neurological Diseases
  • The Prince Charles Hospital
  • Private Practice - Dr PL Morris
  • The Queen Elizabeth Hospital
  • Box Hill Hospital Outpatients
  • Delmont Private Hospital
  • HammondCare
  • NeuroCentrix
  • Bruyère Research Institute
  • Ottawa Memory Clinic
  • Toronto Memory Program
  • Clinique de la Mémoire de l'Outaouais
  • Diex Recherche Sherbrooke Inc.
  • National Center for Geriatrics and Gerontology
  • Himeji Central Hospital Clinic
  • Kobe City Medical Center General Hospital
  • Memory Clinic Toride
  • Katayama Medical Clinic
  • Nozomi Memory Clinic
  • Memory Clinic Ochanomizu
  • Kikukawa Clinic
  • Oita University Hospital
  • Wroclawskie Centrum Alzheimerowskie
  • Centrum Medyczne NEUROMED
  • Centrum Medyczne NeuroProtect
  • Diamond Clinic
  • Podlaskie Centrum Psychogeriatrii
  • Centrum Badan Klinicznych PI-House sp. z o.o.
  • Centrum Medyczne SENIOR
  • Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
  • Centrum Medyczne Euromedis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

LY3372689 High Dose

LY3372689 Low Dose

Placebo

Arm Description

LY3372689 given orally

LY3372689 given orally

Placebo given orally

Outcomes

Primary Outcome Measures

Change from Baseline to End Time Point in Integrated Alzheimer's Disease Rating Scale (iADRS)
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

Change from Baseline to End Time Point in iADRS
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
Change From Baseline to End Time Point in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)
Change From Baseline to End Time Point in CDR-SB
Change from Baseline to End Time Point in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
Change from Baseline to End Time Point in ADAS-Cog13
Change from Baseline to End Time Point in Alzheimer's Disease Cooperative Study Instrumental Activities of Daily Living Inventory (ADCS-iADL)
Change from Baseline to End Time Point in ADCS-iADL
Change from Baseline to End Time Point in Mini Mental State Examination (MMSE)
Change from Baseline to End Time Point in MMSE
Change from Baseline to End Time Point in Brain Tau Deposition as Measured by Flortaucipir F18 PET scan
Change from Baseline to End Time Point in Brain Tau Deposition as Measured by Flortaucipir F18 PET scan
Change from Baseline to End Time Point in Volumetric Magnetic Resonance Imaging (vMRI) Measures
Change from Baseline to End Time Point in Volumetric MRI Measures
Pharmacokinetics (PK) Plasma Concentration of LY3372689
PK Plasma Concentration of LY3372689

Full Information

First Posted
September 14, 2021
Last Updated
October 10, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05063539
Brief Title
A Study of LY3372689 to Assess the Safety, Tolerability, and Efficacy in Participants With Alzheimer's Disease
Official Title
Assessment of Safety, Tolerability, and Efficacy of LY3372689 in Early Symptomatic Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 16, 2021 (Actual)
Primary Completion Date
May 16, 2024 (Anticipated)
Study Completion Date
June 13, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Dementia, Mild Cognitive Impairment, Prodromal Alzheimer's Disease, Tauopathy, Tau, OGA Inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Based on a common closed study design. Participants final endpoint time will be between 76-124 weeks.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LY3372689 High Dose
Arm Type
Experimental
Arm Description
LY3372689 given orally
Arm Title
LY3372689 Low Dose
Arm Type
Experimental
Arm Description
LY3372689 given orally
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo given orally
Intervention Type
Drug
Intervention Name(s)
LY3372689
Intervention Description
given orally
Intervention Type
Drug
Intervention Name(s)
LY3372689
Intervention Description
given orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
given orally
Primary Outcome Measure Information:
Title
Change from Baseline to End Time Point in Integrated Alzheimer's Disease Rating Scale (iADRS)
Description
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
Time Frame
Baseline, 76 to 124 Weeks
Secondary Outcome Measure Information:
Title
Change from Baseline to End Time Point in iADRS
Description
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
Time Frame
Baseline, 76 to 124 Weeks
Title
Change From Baseline to End Time Point in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)
Description
Change From Baseline to End Time Point in CDR-SB
Time Frame
Baseline, 76 to 124 Weeks
Title
Change from Baseline to End Time Point in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
Description
Change from Baseline to End Time Point in ADAS-Cog13
Time Frame
Baseline, 76 to 124 Weeks
Title
Change from Baseline to End Time Point in Alzheimer's Disease Cooperative Study Instrumental Activities of Daily Living Inventory (ADCS-iADL)
Description
Change from Baseline to End Time Point in ADCS-iADL
Time Frame
Baseline, 76 to 124 Weeks
Title
Change from Baseline to End Time Point in Mini Mental State Examination (MMSE)
Description
Change from Baseline to End Time Point in MMSE
Time Frame
Baseline, 76 to 124 Weeks
Title
Change from Baseline to End Time Point in Brain Tau Deposition as Measured by Flortaucipir F18 PET scan
Description
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
Title
Change from Baseline to End Time Point in Volumetric Magnetic Resonance Imaging (vMRI) Measures
Description
Change from Baseline to End Time Point in Volumetric MRI Measures
Time Frame
Baseline, 76 to 124 Weeks
Title
Pharmacokinetics (PK) Plasma Concentration of LY3372689
Description
PK Plasma Concentration of LY3372689
Time Frame
Up to 124 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Hope Clinical Research, Inc.
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Neuro-Pain Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Irvine Clinical Research Center
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Facility Name
Sharp Mesa Vista Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Institute for Neurodegenerative Disorders
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
JEM Research Institute
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
VIN-Julie Schwartzbard
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Neurology Offices of South Florida
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Facility Name
Neuropsychiatric Research Center of Southwest Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Charter Research
City
Lady Lake
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Facility Name
K2 Medical Research
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
ClinCloud - Viera
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32940
Country
United States
Facility Name
Merritt Island Medical Research, LLC
City
Merritt Island
State/Province
Florida
ZIP/Postal Code
32952
Country
United States
Facility Name
Visionary Investigators Network
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
VIN-Victor Faradji
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Suncoast Clinical Research
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
IMIC, Inc.
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
VIN- Margarita Almeida El-Ramey
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
Brain Matters Research
City
Stuart
State/Province
Florida
ZIP/Postal Code
34997
Country
United States
Facility Name
Josephson Wallack Munshower Neurology, PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Eastern Maine Medical Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Boston Center for Memory
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Donald S. Marks M.D., P.C.
City
Plymouth
State/Province
Massachusetts
ZIP/Postal Code
02360
Country
United States
Facility Name
MedVadis Research Corporation
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Facility Name
Adams Clinical
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
The Cognitive and Research Center of New Jersey
City
Springfield
State/Province
New Jersey
ZIP/Postal Code
07081
Country
United States
Facility Name
Advanced Memory Research Institute of New Jersey
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
University at Buffalo - UBMD Neurology
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Abington Neurological Associates, Ltd.
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Keystone Clinical Studies
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
Facility Name
Rhode Island Mood & Memory Research Institute
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Kerwin Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
The Memory Clinic
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201-9810
Country
United States
Facility Name
Central Coast Neurosciences Research (Tumbi Umbi)
City
Central Coast
State/Province
New South Wales
ZIP/Postal Code
2261
Country
Australia
Facility Name
St Vincent's Hospital Sydney
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
HammondCare Greenwich Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Hornsby Ku-Ring-Gai Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2077
Country
Australia
Facility Name
KARA Institute for Neurological Diseases
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2113
Country
Australia
Facility Name
The Prince Charles Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Private Practice - Dr PL Morris
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
The Queen Elizabeth Hospital
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Box Hill Hospital Outpatients
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Delmont Private Hospital
City
Glen Iris
State/Province
Victoria
ZIP/Postal Code
3146
Country
Australia
Facility Name
HammondCare
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
NeuroCentrix
City
Noble Park
State/Province
Victoria
ZIP/Postal Code
3174
Country
Australia
Facility Name
Bruyère Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1N 5C8
Country
Canada
Facility Name
Ottawa Memory Clinic
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Z 1G3
Country
Canada
Facility Name
Toronto Memory Program
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 2S7
Country
Canada
Facility Name
Clinique de la Mémoire de l'Outaouais
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8T 8J1
Country
Canada
Facility Name
Diex Recherche Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Facility Name
National Center for Geriatrics and Gerontology
City
Obu City
State/Province
Aichi
ZIP/Postal Code
4748511
Country
Japan
Facility Name
Himeji Central Hospital Clinic
City
Himeji
State/Province
Hyogo
ZIP/Postal Code
672-8043
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Memory Clinic Toride
City
Toride
State/Province
Ibaraki
ZIP/Postal Code
302-0004
Country
Japan
Facility Name
Katayama Medical Clinic
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
710-0813
Country
Japan
Facility Name
Nozomi Memory Clinic
City
Mitaka-shi
State/Province
Tokyo
ZIP/Postal Code
181-0013
Country
Japan
Facility Name
Memory Clinic Ochanomizu
City
Tokyo
ZIP/Postal Code
113-0034
Country
Japan
Facility Name
Kikukawa Clinic
City
Tokyo
ZIP/Postal Code
179-0072
Country
Japan
Facility Name
Oita University Hospital
City
Yufu
ZIP/Postal Code
879-5503
Country
Japan
Facility Name
Wroclawskie Centrum Alzheimerowskie
City
Wroclaw
State/Province
Dolnośląskie
ZIP/Postal Code
53-659
Country
Poland
Facility Name
Centrum Medyczne NEUROMED
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-163
Country
Poland
Facility Name
Centrum Medyczne NeuroProtect
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-684
Country
Poland
Facility Name
Diamond Clinic
City
Krakow
State/Province
Małopolskie
ZIP/Postal Code
31-559
Country
Poland
Facility Name
Podlaskie Centrum Psychogeriatrii
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-756
Country
Poland
Facility Name
Centrum Badan Klinicznych PI-House sp. z o.o.
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Centrum Medyczne SENIOR
City
Sopot
State/Province
Pomorskie
ZIP/Postal Code
81-855
Country
Poland
Facility Name
Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
61-853
Country
Poland
Facility Name
Centrum Medyczne Euromedis
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
70-111
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://www.vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/6wDcj33niQMZDbeYm8iDfu
Description
A Study of LY3372689 to Assess the Safety, Tolerability, and Efficacy in Participants With Alzheimer's Disease

Learn more about this trial

A Study of LY3372689 to Assess the Safety, Tolerability, and Efficacy in Participants With Alzheimer's Disease

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