Clinical trial NCT05225415: Study to Evaluate the Safety, Tolerability and Efficacy of CT1812 in Subjects With Mild to Moderate Dementia With Lewy Bodies
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 2, 6-month Study to Evaluate the Safety, Tolerability and Exploratory Efficacy of CT1812 in Subjects With Mild to Moderate Dementia With Lewy Bodies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dementia With Lewy Bodies
Keywords: Dementia
Lead sponsor: Cognition Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-02-04
Enrollment: 130
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, placebo-controlled
Primary purpose: TREATMENT

Brief summary: Multi-center, randomized, double-blind, placebo-controlled, 6- month study in subjects with mild to moderate Dementia with Lewy Bodies.

Detailed description: The safety and efficacy of CT1812 at doses of 300 and 100mg will be evaluated over a 24 week double-blind treatment period in patient diagnosed with dementia with Lewy bodies.

Patients will be randomized 1:1:1 to placebo, 100mg CT1812 or 300mg CT1812. Oral CT1812 will be taken daily. Subjects meeting eligibility requirement and signing informed consent will be assessed by repeated psychometric/neurologic testing, safety procedures and PK and PD sample collection at defined intervals throughout the study. Plasma and CSF biomarkers will also be followed.

Eligibility criteria: Inclusion Criteria:

* Men or women 50-85 years of age (inclusive), meeting criteria for probable Dementia with Lewy Bodies (DLB).
* MRI, or CT scan due to contraindication of MRI if approved by medical monitor) obtained during screening consistent with the clinical diagnosis of DLB and without findings of significant exclusionary abnormalities. An historical MRI (or CT scan), up to 1 year prior to screening, may be used if there is no history of intervening neurologic disease or clinical events (such as a stroke, head trauma etc.) and the subject is without clinical symptoms or signs suggestive of such intervening events.
* MMSE 18-27 inclusive

Exclusion Criteria:

* Any neurological condition that may be contributing to cognitive impairment above and beyond those caused by the subject's DLB, including any co-morbidities detected by clinical assessment or MRI (or CT scan due to contraindication of MRI, if approved by medical monitor)
* Screening MRI (or historical MRI or CT scan due to contraindication of MRI if approved by medical monitor) or historical MRI/CT scan, if applicable. of the brain indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct \> 1 cm3, \>3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g. abscess or brain tumor such as meningioma). If a small incidental meningioma is observed, the medical monitor may be contacted to discuss eligibility.
* Clinical, laboratory findings or medical history consistent with:

  1. Other primary degenerative dementia (fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
  2. Other neurodegenerative condition (amyotrophic lateral sclerosis, etc.).
  3. Seizure disorder.
  4. Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, other laboratory values etc.).
* Any major psychiatric diagnosis, including schizophrenia, bipolar disorder, and current major depressive disorder as per Diagnostic and Statistical Manual of Mental Disorders Fifth Edition
* Clinically significant, advanced or unstable disease that may interfere with outcome evaluations.

Primary outcomes:
measure: Safety and Tolerability of CT1812
timeFrame: Baseline, Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 98, Day 126, Day 154, Day 182, Day 210
Secondary outcomes:
measure: Montreal Cognitive Assessment Scale (MoCA)
timeFrame: Baseline, 3 months, 6 months
measure: Epworth Sleepiness Scale (ESS)
timeFrame: Baseline, 3 months, 6 months
measure: Clinician Assessment of Fluctuation (CAF)
timeFrame: Baseline, 3 months, 6 months
measure: ADCS-Clinical Global Impression of Change (CGIC)
timeFrame: Baseline, 3 months, 6 months
measure: ADCS - Activities of Daily Living (ADCS-ADL)
timeFrame: Baseline, 3 months, 6 months
measure: Movement Disorder Society - United Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III)
timeFrame: Baseline, 3 months, 6 months
measure: Cognitive Drug Research Battery (CDR)
timeFrame: Baseline, 3 months, 6 months
measure: Neuropsychiatric Inventory (NPI)
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Sun City
country: United States
facility: Banner Sun Health Research Institute
state: Arizona
city: Tucson
country: United States
facility: University of Arizona - Health Sciences Center
state: Arizona
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Santa Monica
country: United States
facility: Pacific Neuroscience Institute
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Englewood
country: United States
facility: CenExel Rocky Mountain Clinical Research, LLC
state: Colorado
city: Stamford
country: United States
facility: New England Institute for Neurology and Headache (NEINH)
state: Connecticut
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Boca Raton
country: United States
facility: University of Miami Miller School of Medicine Comprehensive Center for Brain Health
state: Florida
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton
state: Florida
city: Lady Lake
country: United States
facility: Charter Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Winter Park
country: United States
facility: Charter Research
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center Section of Parkinson Disease and Movement Disorder
state: Illinois
city: Indianapolis
country: United States
facility: IU Health Neuroscience Center, Goodman Hall
state: Indiana
city: Indianapolis
country: United States
facility: Josephson Wallack Munshower Neurology, P.C
state: Indiana
city: Fairway
country: United States
facility: The University of Kansas Alzheimer's Disease Research Center
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Plymouth
country: United States
facility: Headlands Research Eastern Massachusetts, LLC
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Columbia University
state: New York
city: Chapel Hill
country: United States
facility: UNC Department of Neurology
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Summit Headlands, LLC
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Adult Neurology
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Kirkland
country: United States
facility: Evergreen Health Research
state: Washington
city: Seattle
country: United States
facility: Universtiy of Washington Department of Neurology
state: Washington
Study officials:
affiliation: Cognition Therapeutics Inc.
name: Anthony Caggiano, MD
role: STUDY_DIRECTOR
References: