δ in Dementia Clinical Trials

1. Ambulatory outpatient volunteers with co-informants.

2. Aged 65-100 years

3. Clinical diagnosis of AD, or MCI.

4. Capacity to give informed consent.

5. GDS score (15 item) ≤ 8.

6. No significant visual or hearing impairments

7. Standardized dECog score between 1.0 and 5.0 relative to ADNI's cohort

1. A history of psychosis, including visual hallucinations;

2. History or treatment for Parkinson's, or tremor, or Rapid Eye Movement (REM) behavior disorder;

3. History of bradycardia or syncopal events;

4. Treatment for cancer in the last 5 years (excluding skin cancers);

5. Major surgery in the last year;

6. Treatment for a seizure disorder with anticonvulsants;

7. Treatment for agitation or psychosis with neuroleptics (treatment of anxiety or insomnia allowed);

8. Current treatment with donepezil or any other AChEI or exposure within the last six months

9. With a recently started Donepezil Rx (< 2 weeks), inability to stop Donepezil treatment for 14 days prior to study enrollment.

10. AChEI treatment not appropriate due to negative risk/benefit ratio based on medical Hx and symptoms during screening. Evaluated by PI and referring clinician.

11. Co-participation in another study that the PI feels would pose a safety risk or adversely affect data integrity of this study.