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Effects of Mental Stimulation in Patients With Mild Cognitive Impairment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01212692
First Posted: October 1, 2010
Last Update Posted: December 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Paul B. Rosenberg, Johns Hopkins University
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Theoretically Based Memory Training Intervention in Mild Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by Paul B. Rosenberg, Johns Hopkins University:

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

Secondary Outcome Measures:
  • Clinical Dementia Rating Scale [ Time Frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention ]
  • Digit Symbol Substitution Test [ Time Frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention ]
  • Digit Span [ Time Frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention ]
  • Verbal Fluency Test [ Time Frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention ]
  • Geriatric Depression Scale [ Time Frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention ]
  • Neuropsychiatric Inventory [ Time Frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention ]
  • Recollection Task [ Time Frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention ]
  • N-Back [ Time Frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention ]
  • Rivermead Behavioral Memory Test [ Time Frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention ]
  • Instrumental Activities of Daily Living [ Time Frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention ]
  • Functional Capacities for Activities of Daily Living [ Time Frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention ]
  • Multifactorial Memory Questionnaire [ Time Frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention ]

Enrollment: 63
Study Start Date: October 2010
Study Completion Date: June 2014
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01212692


Locations
United States, Maryland
BPRU, Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute on Aging (NIA)
Investigators
Principal Investigator: Paul B Rosenberg, MD Johns Hopkins University
  More Information

Responsible Party: Paul B. Rosenberg, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01212692     History of Changes
Other Study ID Numbers: NA_00039100
R01AG034934 ( U.S. NIH Grant/Contract )
First Submitted: September 30, 2010
First Posted: October 1, 2010
Last Update Posted: December 9, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders