Effects of Mental Stimulation in Patients With Mild Cognitive Impairment

Phase 2

Completed

• Conditions: Mild Cognitive Impairment (MCI)

• Registration Number: NCT01212692
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-30
• Study First Submitted QC: 2010-09-30
• Study Start: 2010-10
• Study First Posted: 2010-10-01
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-08
• Last Update Posted: 2015-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Self-Ordered Pointing Task	baseline
Trail-Making	9 months post-intervention
Timed Instrumental Activities of Daily Living	9 months post-intervention
Rey Auditory Verbal Learning Test	9 months post-intervention
Self-ordered pointing task	9 months post-intervention

Secondary Outcome Measures

Name	Time	Method
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
Verbal Fluency Test	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

Trial Locations

Locations (1)

BPRU, Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States