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

Treatment of Language and Memory in Patients With Alzheimer's Disease: A Comparison Between Drug Therapy and Drug Therapy Plus Behavioral Intervention

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Behavioral: Spaced Retrieval Training

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72035
      • UAMS Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Alzheimer's Disease (middle stage)

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: I; Drug Plus Behavioral Therapy	Behavioral: Spaced Retrieval Training; Increasing time to remember important information.
No Intervention: II; Drug Therapy Only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Change on Mini-Mental State Examination	End of Study

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Gary H McCullough, Ph.D., University of Arkansas

Study record dates

Study Major Dates

• Study Start: August 1, 2003
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: January 2, 2008
• First Submitted That Met QC Criteria: January 2, 2008
• First Posted (Estimate): January 15, 2008

Study Record Updates

• Last Update Posted (Estimate): January 9, 2017
• Last Update Submitted That Met QC Criteria: November 17, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Treatment; Alzheimer's Disease; Memory
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: g1-10532-03-07