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Effects of Mental Stimulation in Patients With Mild Cognitive Impairment

This study has been completed.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Paul B. Rosenberg, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01212692
First received: September 30, 2010
Last updated: December 8, 2015
Last verified: December 2015

September 30, 2010
December 8, 2015
October 2010
June 2014   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01212692 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Mild Cognitive Impairment (MCI)
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.
  • Experimental: Mentally stimulating activities
    Intervention: Behavioral: mentally stimulating activities
  • Active Comparator: Mentally stimulating activities- other
    Intervention: Behavioral: mentally stimulating activities
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
June 2014
June 2014   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
50 Years to 100 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01212692
NA_00039100
R01AG034934 ( US NIH Grant/Contract Award Number )
No
Not Provided
Not Provided
Not Provided
Paul B. Rosenberg, Johns Hopkins University
Johns Hopkins University
National Institute on Aging (NIA)
Principal Investigator: Paul B Rosenberg, MD Johns Hopkins University
Johns Hopkins University
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP