Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05063539
Other study ID # 18094
Secondary ID I9X-MC-MTAE2021-
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date September 16, 2021
Est. completion date August 6, 2024

Study information

Verified date March 2024
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 330
Est. completion date August 6, 2024
Est. primary completion date July 9, 2024
Accepts healthy volunteers No
Gender All
Age group 60 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
LY3372689
given orally
LY3372689
given orally
Placebo
given orally

Locations

Country Name City State
Australia Box Hill Hospital Outpatients Box Hill Victoria
Australia Central Coast Neurosciences Research (Tumbi Umbi) Central Coast New South Wales
Australia Delmont Private Hospital Glen Iris Victoria
Australia HammondCare Malvern Victoria
Australia NeuroCentrix Noble Park Victoria
Australia Private Practice - Dr PL Morris Southport Queensland
Australia HammondCare Greenwich Hospital Sydney New South Wales
Australia Hornsby Ku-Ring-Gai Hospital Sydney New South Wales
Australia KARA Institute for Neurological Diseases Sydney New South Wales
Australia St Vincent's Hospital Sydney Sydney New South Wales
Australia The Queen Elizabeth Hospital Woodville South Australia
Canada Clinique de la Mémoire de l'Outaouais Gatineau Quebec
Canada Bruyère Research Institute Ottawa Ontario
Canada Ottawa Memory Clinic Ottawa Ontario
Canada Diex Recherche Sherbrooke Inc. Sherbrooke Quebec
Canada Toronto Memory Program Toronto Ontario
Japan Himeji Central Hospital Clinic Himeji Hyogo
Japan Kobe City Medical Center General Hospital Kobe Hyogo
Japan Katayama Medical Clinic Kurashiki Okayama
Japan Nozomi Memory Clinic Mitaka-shi Tokyo
Japan National Center for Geriatrics and Gerontology Obu City Aichi
Japan Kikukawa Clinic Tokyo
Japan Memory Clinic Ochanomizu Tokyo
Japan Memory Clinic Toride Toride Ibaraki
Japan Oita University Hospital Yufu
Poland Podlaskie Centrum Psychogeriatrii Bialystok Podlaskie
Poland Centrum Medyczne NEUROMED Bydgoszcz Kujawsko-pomorskie
Poland Centrum Badan Klinicznych PI-House sp. z o.o. Gdansk Pomorskie
Poland Diamond Clinic Krakow Malopolskie
Poland Nzoz Neuro-Kard Ilkowski i Partnerzy SPL Poznan Wielkopolskie
Poland Centrum Medyczne SENIOR Sopot Pomorskie
Poland Centrum Medyczne Euromedis Szczecin Zachodniopomorskie
Poland Centrum Medyczne NeuroProtect Warszawa Mazowieckie
Poland Wroclawskie Centrum Alzheimerowskie Wroclaw Dolnoslaskie
United States Abington Neurological Associates, Ltd. Abington Pennsylvania
United States JEM Research Institute Atlantis Florida
United States VIN-Julie Schwartzbard Aventura Florida
United States Eastern Maine Medical Center Bangor Maine
United States The Memory Clinic Bennington Vermont
United States Neurology Offices of South Florida Boca Raton Florida
United States University at Buffalo - UBMD Neurology Buffalo New York
United States Hope Clinical Research, Inc. Canoga Park California
United States Kerwin Medical Center Dallas Texas
United States Brain Matters Research Delray Beach Florida
United States Rhode Island Mood & Memory Research Institute East Providence Rhode Island
United States Neuropsychiatric Research Center of Southwest Florida Fort Myers Florida
United States Neuro-Pain Medical Center Fresno California
United States The University of Texas Health Science Center at Houston Houston Texas
United States Josephson Wallack Munshower Neurology, PC Indianapolis Indiana
United States Irvine Clinical Research Center Irvine California
United States Charter Research Lady Lake Florida
United States K2 Medical Research Maitland Florida
United States ClinCloud - Viera Melbourne Florida
United States Merritt Island Medical Research, LLC Merritt Island Florida
United States VIN-Victor Faradji Miami Florida
United States Visionary Investigators Network Miami Florida
United States Institute for Neurodegenerative Disorders New Haven Connecticut
United States Suncoast Clinical Research New Port Richey Florida
United States Boston Center for Memory Newton Massachusetts
United States Renstar Medical Research Ocala Florida
United States IMIC, Inc. Palmetto Bay Florida
United States VIN- Margarita Almeida El-Ramey Pembroke Pines Florida
United States Donald S. Marks M.D., P.C. Plymouth Massachusetts
United States Keystone Clinical Studies Plymouth Meeting Pennsylvania
United States Sharp Neurocognitive Research Center San Diego California
United States The Cognitive and Research Center of New Jersey Springfield New Jersey
United States Brain Matters Research Stuart Florida
United States Advanced Memory Research Institute of New Jersey Toms River New Jersey
United States MedVadis Research Corporation Waltham Massachusetts
United States Adams Clinical Watertown Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Japan,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Baseline, 76 to 124 Weeks
Secondary 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 Baseline, 76 to 124 Weeks
Secondary 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 Baseline, 76 to 124 Weeks
Secondary 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 Baseline, 76 to 124 Weeks
Secondary 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 Baseline, 76 to 124 Weeks
Secondary Change from Baseline to End Time Point in Mini Mental State Examination (MMSE) Change from Baseline to End Time Point in MMSE Baseline, 76 to 124 Weeks
Secondary 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 Baseline, 76 to 124 Weeks
Secondary 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 Baseline, 76 to 124 Weeks
Secondary Pharmacokinetics (PK) Plasma Concentration of LY3372689 PK Plasma Concentration of LY3372689 Up to 124 Weeks
See also
  Status Clinical Trial Phase
Completed NCT04079803 - PTI-125 for Mild-to-moderate Alzheimer's Disease Patients Phase 2
Completed NCT04044495 - Sleep, Rhythms and Risk of Alzheimer's Disease N/A
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT04520698 - Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease N/A
Active, not recruiting NCT04606420 - Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease N/A
Recruiting NCT05820919 - Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase N/A
Terminated NCT03672474 - REGEnLIFE RGn530 - Feasibility Pilot N/A
Completed NCT03430648 - Is Tau Protein Linked to Mobility Function?
Recruiting NCT04949750 - Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease N/A
Recruiting NCT05288842 - Tanycytes in Alzheimer's Disease and Frontotemporal Dementia
Recruiting NCT05557409 - A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation Phase 3
Recruiting NCT04522739 - Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease Phase 4
Completed NCT06194552 - A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07 Phase 1
Completed NCT03239561 - Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants Early Phase 1
Completed NCT03184467 - Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients Phase 2
Active, not recruiting NCT03676881 - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Terminated NCT03487380 - Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Recruiting NCT05328115 - A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease Phase 1
Completed NCT05562583 - SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support N/A