A Study to Evaluate Compensatory Training to Support Everyday Function and Adherence to Brain Healthy Lifestyle Changes in Those at Risk for Alzheimer's Disease
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 19-006676
NCT ID: NCT04118985
Sponsor Protocol Number: 19-006676
About this study
The primary purpose of this study is to evaluate acceptability of a combination compensation development and lifestyle modification program for brain health in those with subjective cognitive complaint without objective impairment measured by: a) the proportion of invited participants who chose to enroll; and b) quantitative and qualitative program satisfaction ratings.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age 50 or older.
- A positive complaint or concern in response to two questions (‘Do you feel like your memory or other aspects of thinking are becoming worse?’ and ‘Does this worry you?’).
- Normal cognitive performance on the Montreal Cognitive Assessment (adjusted for age and education).
- Self-reported independent function in daily life as measure by the Lawson IADL scale (IADL=8).
- English speaking.
- Approval letter from a physician (due to the exercise component).
- We recognize older adults with SC are heterogeneous and have been variably defined, however, our definition conforms to the international Subjective Cognitive Decline Initiative Working Group39 and is consistent with other large scale studies 40, 41.
Exclusion Criteria:
- Known neurological disorder with potential cognitive symptoms (a diagnosis of Parkinson’s disease, epilepsy, a history of significant TBI, etc.).
- Uncontrolled moderate or severe depression (e.g., CES-D > 21).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Dona Locke, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available