Effects of Mental Stimulation in Patients With Mild Cognitive Impairment

A Theoretically Based Memory Training Intervention in Mild Cognitive Impairment

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 Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment (MCI)
• Intervention / Treatment: Behavioral: mentally stimulating activities

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • BPRU, Johns Hopkins Bayview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mentally stimulating activities	Behavioral: mentally stimulating activities; The study will compare the effects of different methods of mental stimulation. The intervention involves 6 classroom-style educational sessions and 10 mental stimulation studies involving computerized memory tasks.
ACTIVE_COMPARATOR: Mentally stimulating activities- other	Behavioral: mentally stimulating activities; The study will compare the effects of different methods of mental stimulation. The intervention involves 6 classroom-style educational sessions and 10 mental stimulation studies involving computerized memory tasks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Self-Ordered Pointing Task	baseline
Trail-Making	baseline
Timed Instrumental Activities of Daily Living	baseline
Rey Auditory Verbal Learning Test	baseline
Self-ordered pointing task	immediately after the intervention
Self-ordered pointing task	3 months post intervention
Self-ordered pointing task	9 months post-intervention
Trail-Making	immediately after the intervention
Trail-Making	3 months post-intervention
Trail-Making	9 months post-intervention
Timed Instrumental Activities of Daily Living	immediately after the intervention
Timed Instrumental Activities of Daily Living	3 months post-intervention
Timed Instrumental Activities of Daily Living	9 months post-intervention
Rey Auditory Verbal Learning Test	immediately after the intevention
Rey Auditory Verbal Learning Test	3 months post-intervention
Rey Auditory Verbal Learning Test	9 months post-intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Geriatric Depression Scale	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
Recollection Task	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
Rivermead Behavioral Memory Test	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
Functional Capacities for Activities of Daily Living	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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Paul B Rosenberg, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: September 30, 2010
• First Submitted That Met QC Criteria: September 30, 2010
• First Posted (ESTIMATE): October 1, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): December 9, 2015
• Last Update Submitted That Met QC Criteria: December 8, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: NA_00039100; R01AG034934 (NIH)