Status:
COMPLETED
Behavioral Interventions to Prevent or Delay Dementia
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Mild Cognitive Impairment
Memory Disorders
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
This study will compare the effectiveness of different combinations of 5 types of behavioral interventions across patient-centered outcomes. It will also evaluate which outcomes (e.g. quality of life,...
Detailed Description
Traditional randomized controlled trials (RCTs) can be thought of as 'additive' trials where randomization leads to the addition of treatments beyond placebo. Participants are confronted with the prob...
Eligibility Criteria
Inclusion
- A candidate for the HABIT program with a diagnosis of amnestic MCI (confirmed at eligibility visit by a Clinical Dementia Rating (CDR) scale of 0.5).
- A cognitively normal care partner who has at least twice-weekly contact with the participant.
- Either not taking or stable on memory medicine(s) (e.g. donepezil) for at least 3 months.
- Fluent in English. (Expanding the program to communities of Spanish- speakers will be a high priority in subsequent dissemination work).
Exclusion
- Inclusion in another clinical trial that would exclude participation. Subject will be considered for participation at the end of such a trial or as appropriate.
- Medically unable to participate in all arms by virtue of visual or auditory impairments or non-ambulatory status.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2018
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT02265757
Start Date
June 1 2014
End Date
March 31 2018
Last Update
February 22 2019
Active Locations (3)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
3
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905