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 @ 3:59 PM
Ignite Modification Date:
2025-12-24 @ 3:59 PM
NCT ID:
NCT02833792
Eligibility Criteria:
Inclusion Criteria:
1. Males or females between 55-80 years of age.
2. Diagnosed with mild to moderate dementia for at least 3 months prior to enrollment, based on the National Institute of Neurological and Communicative
3. Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINDS-ADRDA) Alzheimer's criteria.
4. MMSE between 12-24 (inclusive) at time of enrollment.
5. Amyloid-positive florbetapir PET scan.
Exclusion Criteria:
1. Prior treatment with stem cells.
2. History of intracranial, subdural, or subarachnoid hemorrhage.
3. Subjects with baseline brain MRI showing more than four (4) cerebral microhemorrhages (regardless of their anatomical location or diagnostic characterization as "possible" or "definite"), and/or one (1) or more areas of superficial siderosis, and/or evidence of a prior macrohemorrhage. MRI must include fluid-attenuation inversion recovery (FLAIR) and T2\*-weighted gradient-recalled-echo (GRE) sequences.
4. History of cancer within the past 5 years, with the exception of localized basal or squamous cell carcinoma.
5. History of seizure disorder.
6. Diagnosis of cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL).
7. History of cerebral neoplasm.
8. Myocardial infarction within six months of enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
80 Years
Study:
NCT02833792
Study Brief:
Protocol Section:
NCT02833792