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:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT03597360
Eligibility Criteria:
Inclusion Criteria:
1. Males or females with severe AD dementia (MMSE\<12) between the ages of 70 to 90 years.
2. Meet the criteria of AD (NIA-AA).
3. If on any of the following medications: acetylcholinesterase inhibitors and/or memantine, participants must be on a stable dose for at least 60 days.
4. Clinically stable for at least 3 months.
Exclusion Criteria:
1. Current or past history of malignancy.
2. Previous history of radiotherapy.
3. Neurological disorder other than AD.
4. Currently receiving other experimental treatments.
5. Clinical or imaging evidence of stroke (with more than 1-2 lacunar infarcts on CT scan or MRI).
6. Major depression, bipolar affective disorder or psychosis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Maximum Age:
90 Years
Study:
NCT03597360
Study Brief:
Protocol Section:
NCT03597360