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:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 4:02 PM
NCT ID:
NCT06582706
Eligibility Criteria:
Inclusion Criteria:
Age 60-85 males or females
Clinically have a diagnosis of Alzheimer's disease in the mild-moderate dementia range Mini Mental Status Examination (MMSE) between 14-24 inclusive
Must be on a stable dose (30 days minimum) of a cholinesterase inhibitor and/or memantine (or absence thereof)
Have a reliable co-participant who has at least 3 days of face-to-face contact per week with the patient and ensures medical compliance with the study drug.
Neuroimaging (MRI or CT scan of the brain) should be available within 1 year of screening
Exclusion Criteria:
Any contraindication to clinical lumbar puncture including increased intracranial pressure, posterior fossa mass, bleeding diathesis, use of antiplatelet medications other than aspirin, use of any anticoagulant
Severe cerebrovascular disease
History of large territory stroke
Allergy or sensitivity to B-vitamins or nicotinic acid
History of elevated liver function tests (ALT/AST \> 2x the upper limit of normal) or known liver disease
Current consumption of Vitamin B3 (any form, including nicotinic acid) - including multivitamins and energy drinks. Participants taking a supplement containing Niacin must washout for 4 weeks prior to screening to participate.
Renal impairment of Stage 2 or greater
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
85 Years
Study:
NCT06582706
Study Brief:
Protocol Section:
NCT06582706