Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT05531656
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT05531656
Study Brief:
Protocol Section:
NCT05531656