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Trial record 2 of 5 for:    Miriam Mintzer
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Effects of Mental Stimulation in Patients With Mild Cognitive Impairment

This study is currently recruiting participants.
Verified November 2012 by Johns Hopkins University
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Miriam Mintzer, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01212692
First received: September 30, 2010
Last updated: November 30, 2012
Last verified: November 2012
History of Changes

September 30, 2010
November 30, 2012
October 2010
June 2014   (final data collection date for primary outcome measure)
  • 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 ]
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 ] [ 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 ]
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
Endpoint Classification: Efficacy Study
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.
 
Recruiting
72
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)
Both
50 Years and older
No
Contact: Crystal L Barnhouser, B.A. (410) 550-2688 cbarnhouser@jhmi.edu
United States
 
NCT01212692
NA_00039100, R01AG034934
No
Miriam Mintzer, Johns Hopkins University
Johns Hopkins University
National Institute on Aging (NIA)
Principal Investigator: Miriam Z Mintzer, Ph.D. Johns Hopkins University
Johns Hopkins University
November 2012

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