NCT01212692CompletedPhase 2
A Theoretically Based Memory Training Intervention in Mild Cognitive Impairment
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 63
- Locations
- 2
- Primary Endpoint
- Rey Auditory Verbal Learning Test
Study Overview
Brief Summary
The purpose of this study is to learn if activities that challenge the brain (mentally stimulating activities) can improve memory and other types of thinking in patients with Mild Cognitive Impairment. The study will compare the effects of different methods of mental stimulation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥ 50 years of age
- •meet criteria for amnestic-Mild Cognitive Impairment (MCI)
- •have capacity to give informed consent
- •have capacity to complete assessment measures
Exclusion Criteria
- •history of drug or alcohol dependence
- •severe psychiatric conditions associated with psychosis (e.g., schizophrenia)
- •recent stroke
- •clinical diagnosis of probable Alzheimer's Disease
- •history of seizure disorder, serious head trauma, or other medical, psychiatric, or neurological conditions associated with significant cognitive impairment (e.g., Parkinson's Disease, Korsakoff's, HIV)
- •current use of Alzheimer's Disease medications (e.g., cholinesterase inhibitors, memantine)
Outcomes
Primary Outcomes
Rey Auditory Verbal Learning Test
Time Frame: 9 months post-intervention
Self-Ordered Pointing Task
Time Frame: baseline
Trail-Making
Time Frame: 9 months post-intervention
Timed Instrumental Activities of Daily Living
Time Frame: 9 months post-intervention
Self-ordered pointing task
Time Frame: 9 months post-intervention
Secondary Outcomes
- Verbal Fluency Test(baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention)
- Clinical Dementia Rating Scale(baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention)
- Digit Symbol Substitution Test(baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention)
- Digit Span(baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention)
- N-Back(baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention)
- Instrumental Activities of Daily Living(baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention)
- Neuropsychiatric Inventory(baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention)
- Multifactorial Memory Questionnaire(baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention)
- Geriatric Depression Scale(baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention)
- Recollection Task(baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention)
- Rivermead Behavioral Memory Test(baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention)
- Functional Capacities for Activities of Daily Living(baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention)
Investigators
Paul B. Rosenberg
Associate Professor
Johns Hopkins University
Study Sites (2)
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