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

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ClinicalTrials.gov Identifier: NCT00593372
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : July 20, 2010
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Behavioral: Spaced Retrieval Training Phase 1

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  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2003
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Number of Successful Memory Tasks Completed Over Study Period. [ Time Frame: 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 Outcome Measures :
  1. Change on Mini-Mental State Examination [ Time Frame: End of Study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Alzheimer's Disease (middle stage)

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00593372     History of Changes
Other Study ID Numbers: g1-10532-03-07
First Posted: January 15, 2008    Key Record Dates
Results First Posted: July 20, 2010
Last Update Posted: January 9, 2017
Last Verified: November 2016

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
Neurocognitive Disorders
Mental Disorders