Effects of Mental Stimulation in Patients With Mild Cognitive Impairment - Full Text View

Purpose

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.

Condition	Intervention	Phase
Mild Cognitive Impairment (MCI)	Behavioral: mentally stimulating activities	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Theoretically Based Memory Training Intervention in Mild Cognitive Impairment

Resource links provided by NLM:

MedlinePlus related topics: Memory Mild Cognitive Impairment

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

Self-Ordered Pointing Task [ Time Frame: baseline ] [ Designated as safety issue: No ]
Trail-Making [ Time Frame: baseline ] [ Designated as safety issue: No ]
Timed Instrumental Activities of Daily Living [ Time Frame: baseline ] [ Designated as safety issue: No ]
Rey Auditory Verbal Learning Test [ Time Frame: baseline ] [ Designated as safety issue: No ]
Self-ordered pointing task [ Time Frame: immediately after the intervention ] [ Designated as safety issue: No ]
Self-ordered pointing task [ Time Frame: 3 months post intervention ] [ Designated as safety issue: No ]
Self-ordered pointing task [ Time Frame: 9 months post-intervention ] [ Designated as safety issue: No ]
Trail-Making [ Time Frame: immediately after the intervention ] [ Designated as safety issue: No ]
Trail-Making [ Time Frame: 3 months post-intervention ] [ Designated as safety issue: No ]
Trail-Making [ Time Frame: 9 months post-intervention ] [ Designated as safety issue: No ]
Timed Instrumental Activities of Daily Living [ Time Frame: immediately after the intervention ] [ Designated as safety issue: No ]
Timed Instrumental Activities of Daily Living [ Time Frame: 3 months post-intervention ] [ Designated as safety issue: No ]
Timed Instrumental Activities of Daily Living [ Time Frame: 9 months post-intervention ] [ Designated as safety issue: No ]
Rey Auditory Verbal Learning Test [ Time Frame: immediately after the intevention ] [ Designated as safety issue: No ]
Rey Auditory Verbal Learning Test [ Time Frame: 3 months post-intervention ] [ Designated as safety issue: No ]
Rey Auditory Verbal Learning Test [ Time Frame: 9 months post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical Dementia Rating Scale [ Time Frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention ] [ Designated as safety issue: No ]
Digit Symbol Substitution Test [ Time Frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention ] [ Designated as safety issue: No ]
Digit Span [ Time Frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention ] [ Designated as safety issue: No ]
Verbal Fluency Test [ Time Frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention ] [ Designated as safety issue: No ]
Geriatric Depression Scale [ Time Frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention ] [ Designated as safety issue: No ]
Neuropsychiatric Inventory [ Time Frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention ] [ Designated as safety issue: No ]
Recollection Task [ Time Frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention ] [ Designated as safety issue: No ]
N-Back [ Time Frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention ] [ Designated as safety issue: No ]
Rivermead Behavioral Memory Test [ Time Frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention ] [ Designated as safety issue: No ]
Instrumental Activities of Daily Living [ Time Frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention ] [ Designated as safety issue: No ]
Functional Capacities for Activities of Daily Living [ Time Frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention ] [ Designated as safety issue: No ]
Multifactorial Memory Questionnaire [ Time Frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment:	72
Study Start Date:	October 2010
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212692

Contacts

Contact: Crystal L Barnhouser, B.A.

(410) 550-2688

cbarnhouser@jhmi.edu

Locations

United States, Maryland
BPRU, Johns Hopkins Bayview Medical Center	Recruiting
Baltimore, Maryland, United States, 21224
Principal Investigator: Miriam Z Mintzer, Ph.D.
Sub-Investigator: Constantine G Lyketsos, M.D.
Sub-Investigator: Paul Rosenberg, M.D.

Sponsors and Collaborators

Johns Hopkins University

National Institute on Aging (NIA)

Investigators

Principal Investigator:

Miriam Z Mintzer, Ph.D.

Johns Hopkins University

More Information

No publications provided

Responsible Party:	Miriam Mintzer, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT01212692 History of Changes
Other Study ID Numbers:	NA_00039100, R01AG034934
Study First Received:	September 30, 2010
Last Updated:	November 30, 2012
Health Authority:	United States: Federal Government United States: Institutional Review Board

Additional relevant MeSH terms:

Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013