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Effects of Mental Stimulation in Patients With Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment (MCI)

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

mentally stimulating activities

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment (MCI)

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

BPRU, Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mentally stimulating activities

Mentally stimulating activities- other

Arm Description

Outcomes

Primary Outcome Measures

Self-Ordered Pointing Task

Trail-Making

Timed Instrumental Activities of Daily Living

Rey Auditory Verbal Learning Test

Self-ordered pointing task

Trail-Making

Timed Instrumental Activities of Daily Living

Rey Auditory Verbal Learning Test

Secondary Outcome Measures

Clinical Dementia Rating Scale

Digit Symbol Substitution Test

Digit Span

Verbal Fluency Test

Geriatric Depression Scale

Neuropsychiatric Inventory

Recollection Task

N-Back

Rivermead Behavioral Memory Test

Instrumental Activities of Daily Living

Functional Capacities for Activities of Daily Living

Multifactorial Memory Questionnaire

Full Information

NCT ID

NCT01212692

First Posted

September 30, 2010

Last Updated

December 8, 2015

Sponsor

Johns Hopkins University

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT01212692

Brief Title

Effects of Mental Stimulation in Patients With Mild Cognitive Impairment

Official Title

A Theoretically Based Memory Training Intervention in Mild Cognitive Impairment

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Johns Hopkins University

Collaborators

National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment (MCI)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mentally stimulating activities

Arm Type

Experimental

Arm Title

Mentally stimulating activities- other

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

mentally stimulating activities

Intervention Description

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 Outcome Measure Information:

Title

Self-Ordered Pointing Task

Time Frame

baseline

Title

Trail-Making

Time Frame

baseline

Title

Timed Instrumental Activities of Daily Living

Time Frame

baseline

Title

Rey Auditory Verbal Learning Test

Time Frame

baseline

Title

Self-ordered pointing task

Time Frame

immediately after the intervention

Title

Self-ordered pointing task

Time Frame

3 months post intervention

Title

Self-ordered pointing task

Time Frame

9 months post-intervention

Title

Trail-Making

Time Frame

immediately after the intervention

Title

Trail-Making

Time Frame

3 months post-intervention

Title

Trail-Making

Time Frame

9 months post-intervention

Title

Timed Instrumental Activities of Daily Living

Time Frame

immediately after the intervention

Title

Timed Instrumental Activities of Daily Living

Time Frame

3 months post-intervention

Title

Timed Instrumental Activities of Daily Living

Time Frame

9 months post-intervention

Title

Rey Auditory Verbal Learning Test

Time Frame

immediately after the intevention

Title

Rey Auditory Verbal Learning Test

Time Frame

3 months post-intervention

Title

Rey Auditory Verbal Learning Test

Time Frame

9 months post-intervention

Secondary Outcome Measure Information:

Title

Clinical Dementia Rating Scale

Time Frame