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A Multicenter Rehabilitation Intervention for Amnestic Mild Cognitive Impairment


N/A
18 Years
N/A
Open (Enrolling)
Both
Mild Cognitive Impairment

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Trial Information

A Multicenter Rehabilitation Intervention for Amnestic Mild Cognitive Impairment


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.)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

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).

Outcome Time Frame:

Baseline

Safety Issue:

No

Principal Investigator

Melanie Greenaway, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University

Authority:

United States: Institutional Review Board

Study ID:

1 RO1 NR12419

NCT ID:

NCT01283269

Start Date:

October 2010

Completion Date:

April 2013

Related Keywords:

  • Mild Cognitive Impairment
  • Rehabilitation
  • Cognitive Intervention
  • Prevention
  • Cognition Disorders

Name

Location

Emory University Atlanta, Georgia  30322
Mayo Clinic-Rochester Rochester, Minnesota  55905
Mayo Clinic - Scottsdale Scottsdale, Arizona  85259