A Validation Study of the Novel Application of Telehealth in Clinical Drug Development in Subjects With Mild Cognitive Deficits (REINVENT)

Inclusion Criteria:

• Age at screening 50 to 85 years, inclusive, at the time of informed consent.
• Diagnosis of mild cognitive deficits due to AD based on the core clinical diagnostic criteria of the National Institute of Aging and Alzheimer's Association (Albert 2011; McKhann 2011) and reviewed centrally by a main study site Principal Investigator
• Mini Mental State Examination (MMSE) score of 24-27, inclusive at screening
• Subject (or legally authorized representative) is willing and able to provide written informed consent
• Existence of a reliable study partner (i.e., someone who spends at least 2 days a week with the subject) or caregiver who is willing to attend study visits with the subject
• Willing and able to travel to the main study site (via provided transportation) for either Visit 2 or Visit 3

Exclusion Criteria:

• Any medical or neurological condition (other than AD) that might be a contributing cause of the subject's cognitive impairment
• Have had a stroke or transient ischemic attack (TIA) or unexplained loss of consciousness in the past 1 year
• Clinically significant psychiatric illness in past 6 months
• Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
• Alcohol or substance abuse in past 1 year
• History of unstable angina, myocardial infarction, chronic heart failure (New York Heart Association Class III or IV), or clinically significant conduction abnormalities (e.g., unstable atrial fibrillation) within 1 year prior to Screening.
• Uncontrolled hypertension defined as a systolic blood pressure [SBP]/diastolic blood pressure [DBP] readings > 165/100 mmHg at Screening, or persistent SBP/DBP readings prior to enrollment that in the opinion of the Investigator are indicative of chronic uncontrolled hypertension.
• Any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, or impair the subject's ability to perform cognitive testing.
• Use of allowed chronic medications at doses that have not been stable for at least 4 weeks prior to Screening Visit 1 or use of AD medications (including but not limited to donepezil, rivastigmine, galantamine, tacrine, and memantine) at doses that have not been stable for at least 8 weeks prior to Screening Visit 1.
• Participation in any interventional clinical research study within 30 days prior to screening, or during study conduct
• In the opinion of the Investigator, presence of any other clinical conditions (e.g., life expectancy, co-existing disease) or other characteristics that would likely interfere with completion of the study