Behavioral Interventions to Prevent or Delay Dementia

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment; Mild Dementia; Impaired Cognition; Mild Cognitive Disorder; Amnestic Disorder; Dementia and Amnestic Conditions; Memory Impairment; Memory Disorders; Poor Short-term Memory

• Registration Number: NCT02265757
• Lead Sponsor: Mayo Clinic

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, cognition, function, mood) matter most to people at risk for dementia and their care partners. The results of this study have the potential to direct patients, families, and health care providers as to which combinations of behavioral interventions provide the greatest potential impact on which dementia prevention outcomes. Greater use of behavioral strategies that are targeted to the outcomes of most important to the patient will likely improve patient compliance and treatment adherence. This, in turn, can lessen the need for medication, health care, and long term care utilization.

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 probability of receiving placebo (no treatment). This leads many potential participants to not consent or to withdraw if they believe they are receiving no treatment. In contrast, the proposed trial will be 'subtractive'. This innovative approach to randomization will involve suppression of just 1 of the 5 treatment components. Thus, all participants will receive at least 80% of the menu of interventions offered in this trial.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-10-10
• Study First Submitted QC: 2014-10-10
• Study First Posted: 2014-10-16
• Primary Completion: 2018-03-31
• Study Completion: 2018-03-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-21
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 272

Inclusion Criteria

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 Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Improvement in patient quality of life	baseline to 18 months	quality of life measured by the QOL-AD scale

Secondary Outcome Measures

Name	Time	Method
improvement in caregiver mood and sense of burden	baseline to 18 months	measured by the Caregiver Burden questionnaire and the Center for Epidemiological Studies Depression scale (CESD)
improvement in patient memory based everyday functioning	baseline to 18 months	measured by the Everyday Cognitive Functioning scale (ECOG)

Trial Locations

Locations (3)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States