Clinical trial NCT05063539: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Alzheimer Disease
Keywords: Dementia
Mild Cognitive Impairment
Prodromal Alzheimer's Disease
Tauopathy
Tau
OGA Inhibitor
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-10-01
Enrollment: 330
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Based on a common closed study design. Participants final endpoint time will be between 76-124 weeks.
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change from Baseline to End Time Point in Integrated Alzheimer's Disease Rating Scale (iADRS)
timeFrame: Baseline, 76 to 124 Weeks
Secondary outcomes:
measure: Change from Baseline to End Time Point in iADRS
timeFrame: Baseline, 76 to 124 Weeks
measure: Change From Baseline to End Time Point in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)
timeFrame: Baseline, 76 to 124 Weeks
measure: Change from Baseline to End Time Point in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
timeFrame: Baseline, 76 to 124 Weeks
measure: Change from Baseline to End Time Point in Alzheimer's Disease Cooperative Study Instrumental Activities of Daily Living Inventory (ADCS-iADL)
timeFrame: Baseline, 76 to 124 Weeks
measure: Change from Baseline to End Time Point in Mini Mental State Examination (MMSE)
timeFrame: Baseline, 76 to 124 Weeks
measure: Change from Baseline to End Time Point in Brain Tau Deposition as Measured by Flortaucipir F18 PET scan
timeFrame: Baseline, 76 to 124 Weeks
measure: Change from Baseline to End Time Point in Volumetric Magnetic Resonance Imaging (vMRI) Measures
timeFrame: Baseline, 76 to 124 Weeks
measure: Pharmacokinetics (PK) Plasma Concentration of LY3372689
timeFrame: Up to 124 Weeks
Other outcomes:
Locations:
city: Canoga Park
country: United States
facility: Hope Clinical Research, Inc.
state: California
city: Fresno
country: United States
facility: Neuro-Pain Medical Center
state: California
city: Irvine
country: United States
facility: Irvine Clinical Research
state: California
city: San Diego
country: United States
facility: Sharp Mesa Vista Hospital
state: California
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Aventura
country: United States
facility: VIN-Julie Schwartzbard
state: Florida
city: Boca Raton
country: United States
facility: Neurology Offices of South Florida
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: Fort Myers
country: United States
facility: Neuropsychiatric Research Center of Southwest Florida
state: Florida
city: Maitland
country: United States
facility: K2 Medical Research
state: Florida
city: Melbourne
country: United States
facility: ClinCloud - Viera
state: Florida
city: Merritt Island
country: United States
facility: Merritt Island Medical Research, LLC
state: Florida
city: Miami
country: United States
facility: VIN-Andrew Lerman
state: Florida
city: Miami
country: United States
facility: IMIC, Inc.
state: Florida
city: Miami
country: United States
facility: VIN-Victor Faradji
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Pembroke Pines
country: United States
facility: VIN- Margarita Almeida El-Ramey
state: Florida
city: Stuart
country: United States
facility: Brain Matters Research
state: Florida
city: The Villages
country: United States
facility: Charter Research - Lady Lake
state: Florida
city: Indianapolis
country: United States
facility: Josephson Wallack Munshower Neurology, PC
state: Indiana
city: Newton
country: United States
facility: Boston Center for Memory
state: Massachusetts
city: Plymouth
country: United States
facility: Donald S. Marks M.D., P.C.
state: Massachusetts
city: Waltham
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Watertown
country: United States
facility: Adams Clinical
state: Massachusetts
city: Springfield
country: United States
facility: The Cognitive and Research Center of New Jersey
state: New Jersey
city: Toms River
country: United States
facility: Advanced Memory Research Institute of New Jersey
state: New Jersey
city: Buffalo
country: United States
facility: University at Buffalo - UBMD Neurology
state: New York
city: Abington
country: United States
facility: Abington Neurological Associates, Ltd.
state: Pennsylvania
city: Plymouth Meeting
country: United States
facility: Keystone Clinical Studies
state: Pennsylvania
city: East Providence
country: United States
facility: Rhode Island Mood & Memory Research Institute
state: Rhode Island
city: Dallas
country: United States
facility: Kerwin Medical Center
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Bennington
country: United States
facility: The Memory Clinic
state: Vermont
city: Central Coast
country: Australia
facility: Central Coast Neurosciences Research (Tumbi Umbi)
state: New South Wales
city: Sydney
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Sydney
country: Australia
facility: HammondCare Greenwich Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Hornsby Ku-Ring-Gai Hospital
state: New South Wales
city: Sydney
country: Australia
facility: KARA Institute for Neurological Diseases
state: New South Wales
city: Southport
country: Australia
facility: Private Practice - Dr PL Morris
state: Queensland
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Carlton
country: Australia
facility: NeuroCentrix
state: Victoria
city: Glen Iris
country: Australia
facility: Delmont Private Hospital
state: Victoria
city: Malvern
country: Australia
facility: HammondCare
state: Victoria
city: Ottawa
country: Canada
facility: Bruyère Research Institute
state: Ontario
city: Ottawa
country: Canada
facility: Clinique de la Mémoire de l'Outaouais
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Memory Clinic
state: Ontario
city: Toronto
country: Canada
facility: Toronto Memory Program
state: Ontario
city: Sherbrooke
country: Canada
facility: Diex Recherche Sherbrooke Inc.
state: Quebec
city: Obu City
country: Japan
facility: National Center for Geriatrics and Gerontology
state: Aichi
city: Himeji
country: Japan
facility: Himeji Central Hospital Affiliated Clinic
state: Hyogo
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Toride
country: Japan
facility: Memory Clinic Toride
state: Ibaraki
city: Yufu
country: Japan
facility: Oita University Hospital
state: Oita
city: Kurashiki
country: Japan
facility: Katayama Medical Clinic
state: Okayama
city: Mitaka-shi
country: Japan
facility: Nozomi Memory Clinic
state: Tokyo
city: Nerima
country: Japan
facility: Kikukawa Clinic
state: Tokyo
city: Tokyo
country: Japan
facility: Memory Clinic Ochanomizu
city: Wroclaw
country: Poland
facility: Wroclawskie Centrum Alzheimerowskie
state: Dolnośląskie
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne NEUROMED
state: Kujawsko-pomorskie
city: Warszawa
country: Poland
facility: Centrum Medyczne NeuroProtect
state: Mazowieckie
city: Krakow
country: Poland
facility: Diamond Clinic
state: Małopolskie
city: Białystok
country: Poland
facility: Podlaskie Centrum Psychogeriatrii
state: Podlaskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o.
state: Pomorskie
city: Sopot
country: Poland
facility: Centrum Medyczne SENIOR
state: Pomorskie
city: Poznan
country: Poland
facility: Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
state: Wielkopolskie
city: Szczecin
country: Poland
facility: Centrum Medyczne Euromedis
state: Zachodniopomorskie
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: