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 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT02317250
Eligibility Criteria:
Inclusion Criteria:
1. Cognitive decline and/or personality change is present, as observable by physician and/or close contact(s) of the patient; or in the absence of this, the patient provides a clear history of decline that the patient's physician deems to be reliable.
2. If history or neurologic exam reveals findings suspicious for stroke, tumor, bleed, ictal activity, or hydrocephalus, then CT/MRI and appropriate neurological or neurosurgical consultation must have been obtained.
3. Standard history, physical, and laboratory screen have been performed to identify possible presence of depression, substance abuse, malnourishment, medication effects and interactions, cardiopulmonary compromise, electrolyte/calcium imbalance, anemia, hypoxemia, infection, thyroid dysfunction, renal dysfunction, hepatic dysfunction, or glucose dysregulation.
4. Any positive findings revealed in 2) or 3) above have been appropriately treated, wherever possible, but cognitive/behavioral deficit persists post-therapy.
Exclusion Criteria:
1. Subjects under age 65 will not be recruited, in order to enhance the relevance of the project by focusing on the group of Medicare beneficiaries in whom serious concerns about early signs and symptoms of senile onset dementia are most typically emerging.
2. Cognitive dysfunction has impaired subject's ability to perform activities of daily living.
3. Present or past history of thyroid disease.
4. Claustrophobia or metal in body or other condition that would preclude PET or MRI from being acquired.
5. Visual, auditory or motor deficits that would preclude accurate neuropsychological testing.
6. AD-specific pharmacotherapy already initiated.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT02317250
Study Brief:
Protocol Section:
NCT02317250