Phase 3
N=221
Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment
Mild Cognitive Impairment (MCI)
Bottom Line
View on ClinicalTrials.gov: NCT01299766 ↗Enrolled (actual)
221
Serious AEs
33.9%
Results posted
Nov 2018
Primary outcome: Primary: Number of Participants With a Decline of 6 Points on the Hopkins Verbal Learning Test-Revised (HVLT-R) — 1; 9 Participants — p=.02
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Behavioral Activation (BA) (Behavioral); Supportive Therapy (ST) (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Thomas Jefferson University
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Decline of 6 Points on the Hopkins Verbal Learning Test-Revised (HVLT-R) |
1; 9 | .02 sig |
| SECONDARY Change in University of California Performance-based Skills Assessment (UPSA) Score Per Year |
-.13; -2.60 | .064 |
Summary
The goal of this study is to determine whether increasing participation in cognitive, physical, and/or social activities prevents cognitive decline in older African Americans (AAs) with Mild Cognitive Impairment (MCI). Patients with MCI are at increased risk for Alzheimer's Disease (AD); we propose that increasing participation in activities will prevent cognitive decline and may delay the onset of Alzheimer's Disease (AD). We will test this hypothesis by conducting a clinical trial in which older AAs with MCI (aged 65 years and older) will be randomized to Behavior Activation (BA) (a behavioral intervention that increases participation in daily activities) or Supportive Therapy (ST) (a person-centered psychotherapy that involves active listening and offering support focusing on participants' problems and concerns). We hypothesize that BA-treated subjects will have fewer declines in cognitive and functional abilities, fewer depressive and neuropsychiatric symptoms, and better quality of life than ST-treated subjects at 24 months.
Eligibility Criteria
Inclusion Criteria
- Age 65 years and older
- Having a friend/relative willing to serve as a Knowledgeable Informant (KI)
- Diagnosis of aMCI-MD
- Self-identified as African American
Exclusion Criteria
- Psychiatric diagnosis, including dementia and major depression
- Sensory deficits that preclude neuropsychological testing
- Institutional residence
- Reduced life expectancy due to known terminal illness
Data sourced from ClinicalTrials.gov (NCT01299766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.