Treatment of Language and Memory in Patients With Alzheimer's Disease
1 other identifier
interventional
11
1 country
1
Brief Summary
The purpose of this study is to collect data on the effects of behavioral interventions for memory and communication deficits in persons taking cholinesterase inhibitors compared with the effects of cholinesterase inhibitors alone. Initial testing will include a written case history, tests of communication skills, and interviews with the participants, family, and staff caregivers to help select potential goals for treatment. Participants will be randomly selected to participate in Group A (control) or Group B (intervention). Group A will use a Caregiver Checklist for eight weeks to identify any increase or decrease in the occurrence of the identified communication deficits. Group B will have 16 treatment sessions by a Speech Language Pathologist during the eight-week period. A post test will be administered to all participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 alzheimer-disease
Started Aug 2003
Longer than P75 for phase_1 alzheimer-disease
1 active site
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
Study Start
First participant enrolled
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 2, 2008
CompletedFirst Posted
Study publicly available on registry
January 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
July 20, 2010
CompletedJanuary 9, 2017
November 1, 2016
6.7 years
January 2, 2008
April 27, 2010
November 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Successful Memory Tasks Completed Over Study Period.
Successful memory tasks are those memory tasks (such as "where do I keep my keys") that participants are able to consistently respond to.
8 weeks
Secondary Outcomes (1)
Change on Mini-Mental State Examination
End of Study
Study Arms (2)
I
EXPERIMENTALDrug Plus Behavioral Therapy
II
NO INTERVENTIONDrug Therapy Only
Interventions
Eligibility Criteria
You may qualify if:
- Alzheimer's Disease (middle stage)
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UAMS Medical Center
Little Rock, Arkansas, 72035, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Recruitment of participants was the major limitation of the trial. Alzheimer's patients at facility were asked to participate in so many studies, that participation in this one was challenging.
Results Point of Contact
- Title
- Gary McCullough
- Organization
- UAMS Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Gary H McCullough, Ph.D.
University of Arkansas
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2008
First Posted
January 15, 2008
Study Start
August 1, 2003
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
January 9, 2017
Results First Posted
July 20, 2010
Record last verified: 2016-11