NCT01299766

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2011

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

June 21, 2011

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2016

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

November 20, 2018

Completed
Last Updated

December 12, 2018

Status Verified

November 1, 2018

Enrollment Period

5.5 years

First QC Date

February 16, 2011

Results QC Date

September 18, 2018

Last Update Submit

November 20, 2018

Conditions

Mild Cognitive Impairment (MCI)

Keywords

Mild Cognitive ImpairmentMemory

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With a Decline of 6 Points on the Hopkins Verbal Learning Test-Revised (HVLT-R)

    A decline of 6 points from baseline to 24 months on the Hopkins Verbal Learning Test-Revised (HVLT-R). Possible scores range from 0 to 12, with higher scores indicating better memory.

    24 months

Secondary Outcomes (1)

  • Change in University of California Performance-based Skills Assessment (UPSA) Score Per Year

    24 months

Study Arms (2)

Behavior Activation

EXPERIMENTAL

BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment.

Behavioral: Behavioral Activation (BA)

Supportive Therapy (ST)

PLACEBO COMPARATOR

ST is a person-centered treatment in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions.

Behavioral: Supportive Therapy (ST)

Interventions

Behavioral Activation (BA)BEHAVIORAL

BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment.

Behavior Activation
Supportive Therapy (ST)BEHAVIORAL

ST is a person-centered psychotherapy in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions.

Supportive Therapy (ST)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Psychiatric diagnosis, including dementia and major depression
  • Sensory deficits that preclude neuropsychological testing
  • Institutional residence
  • Reduced life expectancy due to known terminal illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (5)

  • Rovner BW, Casten RJ, Leiby B. Memory improvement in African Americans with amnestic mild cognitive impairment. Int J Geriatr Psychiatry. 2019 Oct;34(10):1447-1454. doi: 10.1002/gps.5141. Epub 2019 Jun 18.

    PMID: 31087388DERIVED

  • Rovner BW, Casten RJ, Hegel MT, Leiby B. Preventing Cognitive Decline in Black Individuals With Mild Cognitive Impairment: A Randomized Clinical Trial. JAMA Neurol. 2018 Dec 1;75(12):1487-1493. doi: 10.1001/jamaneurol.2018.2513.

    PMID: 30208380DERIVED

  • Rovner BW, Casten RJ. Preserving Cognition in Older African Americans with Mild Cognitive Impairment. J Am Geriatr Soc. 2016 Mar;64(3):659-61. doi: 10.1111/jgs.14012. No abstract available.

    PMID: 27000348DERIVED

  • Rovner BW, Casten RJ, Leiby BE. Determinants of Activity Levels in African Americans With Mild Cognitive Impairment. Alzheimer Dis Assoc Disord. 2016 Jan-Mar;30(1):41-6. doi: 10.1097/WAD.0000000000000096.

    PMID: 25811797DERIVED

  • Rovner BW, Casten RJ, Hegel MT, Leiby BE. Preventing cognitive decline in older African Americans with mild cognitive impairment: design and methods of a randomized clinical trial. Contemp Clin Trials. 2012 Jul;33(4):712-20. doi: 10.1016/j.cct.2012.02.016. Epub 2012 Mar 2.

    PMID: 22406101DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Limitations and Caveats

The racial characteristics of the sample and motivation to enroll a clinical trial, limit generalizability. Also, nonrandom attrition (higher in males) may have skewed results.

Results Point of Contact

Title
Robin Casten
Organization
Thomas Jefferson University
robin.casten@jefferson.edu
215-503-1250

Study Officials

  • Robin J Casten, PhD

    Thomas Jefferson University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2011

First Posted

February 18, 2011

Study Start

June 21, 2011

Primary Completion

December 13, 2016

Study Completion

December 13, 2016

Last Updated

December 12, 2018

Results First Posted

November 20, 2018

Record last verified: 2018-11

Locations

US(1)