A Rehabilitation Intervention for Amnestic Mild Cognitive Impairment

Last updated: December 3, 2014
Sponsor: Emory University
Overall Status: Completed

Phase

N/A

Condition

Alzheimer's Disease

Memory Loss

Mild Cognitive Impairment

Treatment

N/A

Clinical Study ID

NCT01283269
IRB00034934
R01NR012419
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Enrolled as a research participant in the Alzheimer's Disease Research Center with aconsensus diagnosis of amnestic Mild Cognitive Impairment (MCI: single domain ormulti-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 programpartner has an MMSE less than 24, the site PI will recommend that the person seekfurther evaluation of cognition through their primary care physician. The person withMCI 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

Exclusion Criteria:

  • Diagnosis other than amnestic MCI (single domain or multi-domain)

  • Visual/hearing impairment or history of reading/writing disability sufficient tointerfere with training

  • Inclusion in another clinical trial that would exclude participation. Subject will beconsidered for participation at the end of such a trial or as appropriate.

  • Baseline score on the self-report depression measure suggesting severe depression foreither the participant or the program partner (>21 on the Centers for EpidemiologicalStudies - Depression Scale (CES-D) and need for psychiatric treatment. (If a patientor program partner has a CES-D greater than 21, the site Principal Investigator willrule out suicidal ideation and then recommend that the person seek further evaluationof mood from their primary care physician, psychiatrist, or other mental healthpractitioner. If they seek treatment and have been stable on that treatment for 3months, they would then be allowed to be reconsidered for the study.)

Study Design

Total Participants: 128
Study Start date:
October 01, 2010
Estimated Completion Date:
July 31, 2014

Connect with a study center

  • Mayo Clinic - Scottsdale

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • Mayo Clinic-Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

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