Treatment of Language and Memory in Patients With Alzheimer's Disease
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.
Alzheimer's Disease. Middle Stage.
Behavioral: Spaced Retrieval Training
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Language and Memory in Patients With Alzheimer's Disease: A Comparison Between Drug Therapy and Drug Therapy Plus Behavioral Intervention|
- Number of Successful Memory Tasks Completed Over Study Period. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Successful memory tasks are those memory tasks (such as "where do I keep my keys") that participants are able to consistently respond to.
- Change on Mini-Mental State Examination [ Time Frame: End of Study ] [ Designated as safety issue: No ]
|Study Start Date:||August 2003|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Drug Plus Behavioral Therapy
Behavioral: Spaced Retrieval Training
Increasing time to remember important information.
No Intervention: II
Drug Therapy Only
Patients with dementia suffer from a variety of cognitive-linguistic deficits, including attention, orientation, memory, anomia, and pragmatics. Behavioral treatment of these deficits falls within the domain of speech-language pathology. While no efficacy studies have emerged to demonstrate the benefit of speech-language therapy for individuals who suffer Alzheimer's disease (AD), data are emerging which support the positive effects of memory and communication intervention in this population. Phase I and Phase II investigations are beginning to provide evidence that such intervention should focus on the development of innovative strategies to help patients compensate for the disabilities resulting from the disease rather than on traditional rehabilitation of impairment. The benefits of cholinesterase inhibitors for improving cognitive function in persons with AD have been demonstrated, and data continue to emerge on specific drugs and specific changes in cognitive processes. The purpose of the proposed investigation would be to collect pilot data on the effects of behavioral intervention for memory and communication deficits in conjunction with cholinesterase inhibitors, as compared with the effects of cholinesterase inhibitors used in isolation. Participants will be individuals with AD who are recruited from the Alzheimer's Disease Center at The University of Arkasas for Medical Sciences Medical Center. All participants will be taking cholinesterase inhibitors, and half of all participants will be randomly selected to receive intervention by a speech-language pathologist. Intervention will consist of 16 treatment sessions (one hour each) over a two month period and will focus on strategies for enhancing memory and functional communication.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593372
|United States, Arkansas|
|UAMS Medical Center|
|Little Rock, Arkansas, United States, 72035|
|Principal Investigator:||Gary H McCullough, Ph.D.||University of Arkansas|