A Rehabilitation Intervention for Amnestic Mild Cognitive Impairment

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Mayo Clinic
Information provided by (Responsible Party):
Melanie C Greenaway, Emory University
ClinicalTrials.gov Identifier:
NCT01283269
First received: January 11, 2011
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

Mild Cognitive Impairment (MCI) is often an early manifestation of Alzheimer's disease (AD). The ability to identify MCI has led to hope that health prevention models might work in AD as they have in cancer and heart disease. Interventions which help sustain functioning in MCI may delay progression to a clinical AD diagnosis. To date, interventions aimed at maintaining functioning in MCI have been pharmacologic in nature. The efficacy of these medications in MCI is controversial, and those with MCI are also often interested in other activities they can do to manage their memory loss.

When an individual is noted to have memory difficulties or MCI, a recommendation is often given for the patient to begin taking notes/using a calendar to help with memory or do cognitively stimulating activities. However, there is currently little instruction about how/what specific activities one should do and how effective they may be. The overall goal of this pilot project is to refine delivery of the Memory Support System (MSS)as a formal compensatory program for memory loss in MCI. Enrollment and retention data will be carefully investigated across 6 week and 10 day intervention groups. The investigators will compare participant adherence to the notebook training in the 6 week and 10 day versions of the intervention to the computer activity group. The investigators will also collect data on the clinical efficacy of the notebook and computer training to investigate if these interventions can sustain/improve functional level. Long term goals for this project also include delaying relocation for persons with MCI who may progress to dementia, thus not only improving the lives of these individuals, but also reducing health care expenditures.

The investigators will recruit a total of 60 individuals with MCI and their 60 program partners across all three sites for this project. At least 16 of these pairs will be recruited at Emory University (maximum of 20 pairs/40 individuals anticipated). The investigators will randomly assign participants to the 6 week notebook or computer training or 10 day notebook or computer training. All participants will also receive patient education regarding MCI and cognitive health.

Subsequent compliance with the MSS will be examined at 3 months, 6 months, and then annually following the intervention. Outcome measures will provide a detailed, multi-modal assessment of participants' functional level, overall cognitive functioning, mood, and self-efficacy, as well as caregiver burden and mood.


Condition Intervention
Mild Cognitive Impairment
Behavioral: Memory Support System
Behavioral: Computer Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Multicenter Rehabilitation Intervention for Amnestic Mild Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • To assess participant adherence to Memory Support System (MSS) use at different levels (6 week, 10 day, or computer activity) of the training intervention. This will be measured by an overall adherence score (Adherence Assessment). [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • To assess participant adherence to (Memory Support System) MSS use at different levels (6 week, 10 day, or computer activity) of the training intervention. This will be measured by an overall adherence score (Adherence Assessment). [ Time Frame: Intervention End ] [ Designated as safety issue: No ]
  • To assess participant adherence to (Memory Support System)MSS use at different levels (6 week, 10 day, or computer activity) of the training intervention. This will be measured by an overall adherence score (Adherence Assessment). [ Time Frame: 3 Month post intervention ] [ Designated as safety issue: No ]
  • To assess participant adherence to (Memory Support System) MSS use at different levels (6 week, 10 day, or computer activity) of the training intervention. This will be measured by an overall adherence score (Adherence Assessment). [ Time Frame: 6 Months post intervention ] [ Designated as safety issue: No ]
  • To assess participant adherence to (Memory Support System) MSS use at different levels (6 week, 10 day, or computer activity) of the training intervention. This will be measured by an overall adherence score (Adherence Assessment). [ Time Frame: 1 Year post intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Memory Support System or Computer Behavioral: Memory Support System
Training in use of a memory notebook system
Other Names:
  • Memory Support System
  • MSS
Behavioral: Computer Training
Computer brain fitness training
Other Name: POSIT

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Enrolled as a research participant in the Alzheimer's Disease Research Center with a consensus diagnosis of amnestic Mild Cognitive Impairment (MCI: single domain or multi-domain).
  • Has a program partner that has at least twice weekly contact with the participant
  • Dementia Rating Scale-2nd Edition (DRS-2) score of 115 or greater
  • Functional Ability Questionnaire (FAQ) score below 6.
  • Program Partner with Mini Mental State Exam (MMSE) of 24 or greater. (If a program partner has an MMSE less than 24, the site PI will recommend that the person seek further evaluation of cognition through their primary care physician. The person with MCI will be encouraged to find an alternate program partner.)
  • Either not taking or stable on nootropic(s) for at least 3 months
  • Has English as primary language

Exclusion Criteria:

  • Diagnosis other than amnestic MCI (single domain or multi-domain)
  • Visual/hearing impairment or history of reading/writing disability sufficient to interfere with training
  • 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.
  • Baseline score on the self-report depression measure suggesting severe depression for either the participant or the program partner (>21 on the Centers for Epidemiological Studies - Depression Scale (CES-D) and need for psychiatric treatment. (If a patient or program partner has a CES-D greater than 21, the site Principal Investigator will rule out suicidal ideation and then recommend that the person seek further evaluation of mood from their primary care physician, psychiatrist, or other mental health practitioner. If they seek treatment and have been stable on that treatment for 3 months, they would then be allowed to be reconsidered for the study.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283269

Locations
United States, Arizona
Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States, 85259
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
United States, Minnesota
Mayo Clinic-Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Emory University
Mayo Clinic
Investigators
Principal Investigator: Melanie Greenaway, PhD Emory University
Principal Investigator: Dona EC Locke, PhD Mayo Clinic
  More Information

No publications provided

Responsible Party: Melanie C Greenaway, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT01283269     History of Changes
Other Study ID Numbers: IRB00034934, R01NR012419
Study First Received: January 11, 2011
Last Updated: November 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Rehabilitation
Cognitive Intervention
Prevention

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014