NCT00611312

Brief Summary

The purpose of this study is to see if an intense two-week long cognitive training program helps the thinking ability of adults with very mild Alzheimer Disease. We anticipate that scores on clinical cognitive tests will be better after the training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2008

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2008

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2008

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

October 3, 2012

Status Verified

October 1, 2012

Enrollment Period

4.2 years

First QC Date

January 28, 2008

Last Update Submit

October 2, 2012

Conditions

Keywords

Alzheimer's diseaseCognitive training

Outcome Measures

Primary Outcomes (1)

  • Composite score of 5 cognitive tests including 1)WAIS digit span, 2) word fluency, 3) trail making test-A 4) Rey Osterrieth complex figure and 5) MMSE

    2 weeks with FU at 2 and 4 months

Secondary Outcomes (1)

  • Brain activity during functional brain imaging

    2 weeks

Study Arms (1)

1

EXPERIMENTAL

Cognitive Training

Behavioral: Cognitive Training

Interventions

Intense cognitive training, two consecutive weeks, each weekday, 6 hours/day

1

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of very mild Alzheimer's Disease (CDC of 0.5) and mild Alzheimer's Disease (CDC of 1.0)

You may not qualify if:

  • Neurologic disorder other than Alzheimer's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Yvonne Colgrove, PhD, PT

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 28, 2008

First Posted

February 8, 2008

Study Start

February 1, 2008

Primary Completion

May 1, 2012

Study Completion

September 1, 2012

Last Updated

October 3, 2012

Record last verified: 2012-10

Locations