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Treatment of Language and Memory in Patients With Alzheimer's Disease

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Spaced Retrieval Training
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer's Disease, Memory, Treatment

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Alzheimer's Disease (middle stage)

Exclusion Criteria:

  • None

Sites / Locations

  • UAMS Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

I

II

Arm Description

Drug Plus Behavioral Therapy

Drug Therapy Only

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change on Mini-Mental State Examination

Full Information

First Posted
January 2, 2008
Last Updated
November 17, 2016
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT00593372
Brief Title
Treatment of Language and Memory in Patients With Alzheimer's Disease
Official Title
Treatment of Language and Memory in Patients With Alzheimer's Disease: A Comparison Between Drug Therapy and Drug Therapy Plus Behavioral Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer's Disease, Memory, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Description
Drug Plus Behavioral Therapy
Arm Title
II
Arm Type
No Intervention
Arm Description
Drug Therapy Only
Intervention Type
Behavioral
Intervention Name(s)
Spaced Retrieval Training
Intervention Description
Increasing time to remember important information.
Primary Outcome Measure Information:
Title
Number of Successful Memory Tasks Completed Over Study Period.
Description
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
Secondary Outcome Measure Information:
Title
Change on Mini-Mental State Examination
Time Frame
End of Study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Alzheimer's Disease (middle stage) Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary H McCullough, Ph.D.
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAMS Medical Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72035
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treatment of Language and Memory in Patients With Alzheimer's Disease

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