A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease

Launched by COGNITION THERAPEUTICS · Sep 2, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new medication called CT1812 to see if it is safe and effective for people with early Alzheimer's disease. The study is specifically for adults aged 50 to 85 who have been diagnosed with mild cognitive impairment due to Alzheimer's or mild Alzheimer's dementia. To participate, individuals must have a certain level of cognitive function, as measured by a test called the MMSE, and have brain scans that show signs of Alzheimer's disease.

Participants in the trial will be randomly assigned to receive either CT1812 or a placebo (a harmless pill with no active ingredients) for comparison. This means that neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo until the study is completed. This helps ensure that the results are reliable. If you or a loved one is interested in joining this study, it’s important to note that individuals with certain other health conditions or significant brain abnormalities will not be eligible. Overall, this trial aims to gather important information that could lead to better treatments for early Alzheimer's disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Ages 50-85 years.
• • 2. Diagnosis of either MCI due to AD or mild AD dementia.
• • 3. MMSE 20-30 (inclusive).
• • 4. Amyloid PET scan of the brain or CSF biomarkers consistent with AD.
• • 5. Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosis of Alzheimer's disease, as based on central read.
• Exclusion Criteria:
• • 1. Screening MRI of the brain indicative of significant abnormality.
• • 2. Clinically significant abnormalities in screening laboratory tests.
• 3. Clinical or laboratory findings consistent with:
• • 1. Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
• • 2. Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.).
• • 3. Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12, other laboratory values etc.)
• • 4. A participant known to be actively infected with hepatitis B or hepatitis C at screening. History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for hepatitis B surface antigen \[HbsAg\] or anti-hepatitis C \[HCV\] antibody). Participants who have evidence of resolved hepatitis infection (e.g., HCV RNA negative) may be considered following discussion with the Medical Monitor.
• • 5. A current DSM-V diagnosis of active major depression or GDS \> 6, schizophrenia, or bipolar disorder.