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

This study has been completed.
Sponsor:
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00593372
First received: January 2, 2008
Last updated: July 27, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease. Middle Stage.
 Behavioral: Spaced Retrieval Training
 Phase 1

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Change on Mini-Mental State Examination [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: August 2003
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
Drug Plus Behavioral Therapy
 Behavioral: Spaced Retrieval Training
Increasing time to remember important information.
No Intervention: II
Drug Therapy Only

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Alzheimer's Disease (middle stage)

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593372

Locations
United States, Arkansas
UAMS Medical Center
Little Rock, Arkansas, United States, 72035
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Gary H McCullough, Ph.D. University of Arkansas
  More Information

No publications provided

Responsible Party: Gary H. McCullough, UArkansas
ClinicalTrials.gov Identifier: NCT00593372     History of Changes
Other Study ID Numbers: g1-10532-03-07
Study First Received: January 2, 2008
Results First Received: April 27, 2010
Last Updated: July 27, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arkansas:
Alzheimer's Disease
Memory
Treatment

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013