The PREVENTION Trial: Precision Recommendations to Optimize Neurocognition (PREVENTION)

This is an interventional supportive care trial for Alzheimer Disease focused on measuring Alzheimer Disease, Mild Cognitive Impairment, Precision Medicine, Health Coaching, Multi-Modal Intervention, Personal, Dense, Dynamic Data (PD3) Clouds, Cognitive decline Read More

Inclusion Criteria

• Subjects must be age 50 to 80 at time of informed consent.
• Subjects of any gender, race or ethnicity are eligible to enroll in the study.
• Subjects must have a FAST stage of 2-4.
• Subjects with FAST Stage 4 must have a caregiver or legally appointed representative willing to accompany participants to the required procedures.
• As part of the study screening procedure, subjects must be willing to undergo an amyloid PET scan or have previously undergone an amyloid PET scan and agree to make the results available. Subjects must be amyloid positive to be eligible to enroll in the study.
• Subjects must be proficient in spoken and written English for consenting as well as for study participation since the intervention in this study (e.g., coaching program) is currently only available in English.
• Subjects with medical conditions must be stable for these conditions. Stable control on medication is acceptable. Subjects should not have started any new medications for chronic conditions within the last three months.
• A neurological and physical evaluation will be conducted prior to enrollment of the study by a qualified medical doctor and confirmed through medical records that they do not possess any abnormal physical or neurological sign, and/ whether they are considered to be clinically significant. Also an MMSE >19 will be confirmed by a medical doctor prior to study enrollment.
• Subjects, with or without assistance, must be able to use a computer and web interface. If assistance is needed, it must be readily available to them.
• Subjects must be able to converse with a coach telephonically. Video-based telephone coaching is part of data-driven health coaching.
• Subjects must have regular access to a computer and the Internet along with dedicated email address since certain aspects of the program (e.g. cognitive training) are delivered electronically.
• Subject must have normal visual acuity (or corrected to normal) and normal color vision as indicated by self-report.
• Subject must have adequate hearing acuity as indicated by self-report.
• Subject must have adequate motor capacity to use a mobile phone/iPad/computer as indicated by self-report and confirmed by staff before they are enrolled into a treatment arm.
• Subject must be cleared by a physician to participate in a moderately intensive exercise program.

Exclusion Criteria

• Subjects with an existing diagnosis of a non-AD neurodegenerative disorder (e.g., Lewy Body Dementia, Frontal-Temporal Dementia).
• Subjects with a diagnosis of cerebrovascular disease as the primary cause of cognitive impairment.
• A previously reported AD high-risk mutation (e.g., in the Presenilin Protein (PSEN) or Amyloid Precursor Protein (APP) genes) in the participant or immediate family (children, siblings, or parents). Such patients may accumulate amyloid faster than in late onset AD, and therefore may show less pronounced benefit from intervention.
• Mini Mental State Exam (MMSE) below 20.
• Clinical Dementia Rating (CDR) global score of 2 or above.