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Completed

NCT Number: NCT01212692

Effects of Mental Stimulation in Patients With 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.

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Key information

Conditions

Mild Cognitive Impairment (MCI) Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

BPRU, Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

mentally stimulating activities

Behavioral

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.

Primary outcomes

  1. Self-Ordered Pointing Task

    Time frame: baseline

  2. Trail-Making

    Time frame: baseline

  3. Timed Instrumental Activities of Daily Living

    Time frame: baseline

  4. Rey Auditory Verbal Learning Test

    Time frame: baseline

  5. Self-ordered pointing task

    Time frame: immediately after the intervention

  6. Self-ordered pointing task

    Time frame: 3 months post intervention

  7. Self-ordered pointing task

    Time frame: 9 months post-intervention

  8. Trail-Making

    Time frame: immediately after the intervention

  9. Trail-Making

    Time frame: 3 months post-intervention

  10. Trail-Making

    Time frame: 9 months post-intervention

  11. Timed Instrumental Activities of Daily Living

    Time frame: immediately after the intervention

  12. Timed Instrumental Activities of Daily Living

    Time frame: 3 months post-intervention

  13. Timed Instrumental Activities of Daily Living

    Time frame: 9 months post-intervention

  14. Rey Auditory Verbal Learning Test

    Time frame: immediately after the intevention

  15. Rey Auditory Verbal Learning Test

    Time frame: 3 months post-intervention

  16. Rey Auditory Verbal Learning Test

    Time frame: 9 months post-intervention

Secondary outcomes

  1. Clinical Dementia Rating Scale

    Time frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention

  2. Digit Symbol Substitution Test

    Time frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention

  3. Digit Span

    Time frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention

  4. Verbal Fluency Test

    Time frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention

  5. Geriatric Depression Scale

    Time frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention

  6. Neuropsychiatric Inventory

    Time frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention

  7. Recollection Task

    Time frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention

  8. N-Back

    Time frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention

  9. Rivermead Behavioral Memory Test

    Time frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention

  10. Instrumental Activities of Daily Living

    Time frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention

  11. Functional Capacities for Activities of Daily Living

    Time frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention

  12. Multifactorial Memory Questionnaire

    Time frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

A Theoretically Based Memory Training Intervention in Mild Cognitive Impairment

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Oct 1, 2010
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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