Full Text View
Tabular View
No Study Results Posted
Related Studies
Treatment of Language and Memory in Patients With Alzheimer's Disease
This study is currently recruiting participants.
Verified by University of Arkansas, February 2009
First Received: January 2, 2008   Last Updated: February 12, 2009   History of Changes
Sponsored by: University of Arkansas
Information provided by: University of Arkansas
ClinicalTrials.gov Identifier: NCT00593372
  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 I

Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Disease Memory
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Treatment of Language and Memory in Patients With Alzheimer's Disease: A Comparison Between Drug Therapy and Drug Therapy Plus Behavioral Intervention

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Number of successful memory tasks completed over study period. [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • Score on Modified Mini-Mental State Examination [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2003
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
I: Experimental
Drug Plus Behavioral Therapy
Behavioral: Spaced Retrieval Training
Increasing time to remember important information.
II: No Intervention
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 ADC at UAMS. 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

Contacts
Contact: Gary H McCullough, Ph.D. 501-428-1234 mcculloughgaryh@uams.edu

Locations
United States, Arkansas
UAMS Medical Center Recruiting
Little Rock, Arkansas, United States, 72035
Contact: Gary H McCullough, Ph.D.     501-428-1234     mcculloughgaryh@uams.edu    
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Gary H McCullough, Ph.D. University of Arkansas
  More Information

No publications provided

Responsible Party: UArkansas ( Gary H. McCullough )
Study ID Numbers: g1-10532-03-07
Study First Received: January 2, 2008
Last Updated: February 12, 2009
ClinicalTrials.gov Identifier: NCT00593372     History of Changes
Health Authority: United States: National Institute on Aging

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

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

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

ClinicalTrials.gov processed this record on May 07, 2009