NCT01212692

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 9, 2015

Status Verified

December 1, 2015

Enrollment Period

3.7 years

First QC Date

September 30, 2010

Last Update Submit

December 8, 2015

Conditions

Mild Cognitive Impairment (MCI)

Outcome Measures

Primary Outcomes (16)

  • Self-Ordered Pointing Task

    baseline

  • Trail-Making

    baseline

  • Timed Instrumental Activities of Daily Living

    baseline

  • Rey Auditory Verbal Learning Test

    baseline

  • Self-ordered pointing task

    immediately after the intervention

  • Self-ordered pointing task

    3 months post intervention

  • Self-ordered pointing task

    9 months post-intervention

  • Trail-Making

    immediately after the intervention

  • Trail-Making

    3 months post-intervention

  • Trail-Making

    9 months post-intervention

  • Timed Instrumental Activities of Daily Living

    immediately after the intervention

  • Timed Instrumental Activities of Daily Living

    3 months post-intervention

  • Timed Instrumental Activities of Daily Living

    9 months post-intervention

  • Rey Auditory Verbal Learning Test

    immediately after the intevention

  • Rey Auditory Verbal Learning Test

    3 months post-intervention

  • Rey Auditory Verbal Learning Test

    9 months post-intervention

Secondary Outcomes (12)

  • Clinical Dementia Rating Scale

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

  • Digit Symbol Substitution Test

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

  • Digit Span

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

  • Verbal Fluency Test

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

  • Geriatric Depression Scale

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

  • +7 more secondary outcomes

Study Arms (2)

Mentally stimulating activities

EXPERIMENTAL
Behavioral: mentally stimulating activities

Mentally stimulating activities- other

ACTIVE COMPARATOR
Behavioral: mentally stimulating activities

Interventions

mentally stimulating activitiesBEHAVIORAL

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.

Mentally stimulating activitiesMentally stimulating activities- other

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 50 years of age
  • meet criteria for amnestic-Mild Cognitive Impairment (MCI)
  • have capacity to give informed consent
  • have capacity to complete assessment measures

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BPRU, Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Paul B Rosenberg, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 30, 2010

First Posted

October 1, 2010

Study Start

October 1, 2010

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

December 9, 2015

Record last verified: 2015-12

Locations

US(1)