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

Alzheimer Disease Clinical Trial

Official title:

Assessment of Safety, Tolerability, and Efficacy of LY3372689 in Early Symptomatic Alzheimer's Disease

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
• Start date: September 16, 2021
• Est. completion date: August 6, 2024

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Alzheimer Disease

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	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	Irvine	California
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, Inc.	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	Charter Research - Lady Lake	The Villages	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

External Links

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