Behavioral Interventions to Prevent or Delay Dementia

Status:	Completed
Conditions:	Alzheimer Disease, Cognitive Studies, Neurology
Therapuetic Areas:	Neurology, Psychiatry / Psychology
Healthy:	No
Age Range:	50 - Any
Updated:	2/24/2019
Start Date:	June 2014
End Date:	March 31, 2018

Comparative Effectiveness of Behavioral Interventions to Prevent or Delay Dementia (CEBIPODD)

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.

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.

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.

We found this trial at

sites

Mayo Clinic Florida

4500 San Pablo Rd S
Jacksonville, Florida 32224

(904) 953-2000