Alzheimer Disease
Conditions
Keywords
Alzheimer's Disease, Memory, Treatment
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.
Detailed description
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.
Interventions
BEHAVIORALSpaced Retrieval Training
Increasing time to remember important information.
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Alzheimer's Disease (middle stage)
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Successful Memory Tasks Completed Over Study Period. | 8 weeks | Successful memory tasks are those memory tasks (such as where do I keep my keys) that participants are able to consistently respond to. |
Secondary
| Measure | Time frame |
|---|---|
| Change on Mini-Mental State Examination | End of Study |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spaced Retrieval Therapy Participants continue on current medication but participate in spaced retrieval memory training, as well. | 8 |
| Continuing Medication Only Participants continue on current medication and are assessed at beginning and end of study duration. | 3 |
| Total | 11 |
Baseline characteristics
| Characteristic | Continuing Medication Only | Spaced Retrieval Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 7 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Continuous | 72 years STANDARD_DEVIATION 3 | 74 years STANDARD_DEVIATION 5 | 72 years STANDARD_DEVIATION 6 |
| Gender Female | 2 Participants | 2 Participants | 4 Participants |
| Gender Male | 1 Participants | 6 Participants | 7 Participants |
| Region of Enrollment United States | 3 participants | 8 participants | 11 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 3 |
| serious Total, serious adverse events | 0 / 8 | 0 / 3 |
Outcome results
Primary
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.
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spaced Retrieval Therapy | Number of Successful Memory Tasks Completed Over Study Period. | 5 memory tasks |
| Continuing Medication Only | Number of Successful Memory Tasks Completed Over Study Period. | 0 memory tasks |
Secondary
Change on Mini-Mental State Examination
Time frame: End of Study