Status:
COMPLETED
Study to Evaluate the Safety, Tolerability and Efficacy of CT1812 in Subjects With Mild to Moderate Dementia With Lewy Bodies
Lead Sponsor:
Cognition Therapeutics
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Dementia With Lewy Bodies
Eligibility:
All Genders
50-85 years
Phase:
PHASE2
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 random...
Eligibility Criteria
Inclusion
- 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
- 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:
- Other primary degenerative dementia (fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
- Other neurodegenerative condition (amyotrophic lateral sclerosis, etc.).
- Seizure disorder.
- 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.
Key Trial Info
Start Date :
May 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2024
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT05225415
Start Date
May 19 2022
End Date
November 25 2024
Last Update
June 15 2025
Active Locations (34)
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1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
2
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
3
University of Arizona - Health Sciences Center
Tucson, Arizona, United States, 85724
4
Stanford University
Palo Alto, California, United States, 94304