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 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
NCT ID:
NCT02914366
Eligibility Criteria:
Inclusion Criteria:
1. Age \>50,
2. Mild to Moderate Dementia (established by an upper cut off of a Montreal Cognitive Assessment score of 24 or below, and the lower bound by a Mini Mental State Exam of 16 or greater),
3. Parkinson's Disease (Hoehn \& Yahr stage 2 - 3.5) clearly established more than 1 year before the onset of dementia
4. Patients must have a responsible caregiver = 4 days/wk
5. Must be on stable doses of medications for Parkinson's disease mood and cognition (Cholinesterase Inhibitor) for at least 3 months prior to the study.
Exclusion Criteria:
1. Evidence of clinically significant stroke or other neurological condition
2. Any other serious underlying condition (i.e. cancer or unstable cardiac disease etc.
3. Concurrent treatment with oral anticoagulants (including Vitamin K agonists and Novel Oral Anticoagulants (NOACs)) within 4 weeks of screening or anticipated during the 52 week double-blind and open label periods. Specifically, Apixaban, Dabigatran, Edoxaban, Fondaparinux, Rivaroxaban, and Warfarin are prohibited concomitant medications.
3.1 Exceptions: antiplatelet agents such as Aspirin, Clopidogrel, and Aggrenox are allowed.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT02914366
Study Brief:
Protocol Section:
NCT02914366