Monday, August 11, 2008

Memantine and Comprehensive, Individualized Management of Alzheimer's Patients and Caregiver Training

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Phase IV clinical trial, Alzheimer's Disease,
Behavioral: Caregiver Training Home visits: exercising, doing activities
Drug: memantine

Presently some 4.5 million people are afflicted with Alzheimer's disease in the United States. At present pharmacologic treatment, although beneficial, is not curative. Certain nonpharmacologic treatments have assisted caregivers of AD patients by reducing their stress and burden, and others have aided patients, by improving their mood and physical functioning. Comprehensive, individualized approaches to improving Alzheimer's patients' symptomatology and caregiver stress and burden have not been systematically investigated in Alzheimer's patient care. This study seeks to train and counsel caregivers as well as develop an individualized, comprehensive management program that will seek to enhance the functioning of each patient participant.



Memantine and Comprehensive, Individualized Management of Alzheimer's Patients and Caregiver Training


Eligibility
Ages Eligible for Study: 50 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

* Patients, 50 years of age or greater, residing in the community
* Presence of a family and/or professional caregiver willing and able to participate in all aspects of this study
* A diagnosis of probable Alzheimer's disease by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) and NINCDS-ADRDA (McKhann,et al., Neurology,1984;34: 939-944) criteria
* A CT or MRI brain scan and medical work up compatible with the DSM-IV and NINCDS-ADRDA diagnostic criteria for Alzheimer's disease
* Mini-Mental State Examination scores of 3-14
* Global Deterioration Scale stages of 5 or 6
* A stage of 6a or greater on the Functional Assessment Staging instrument signifying the presence of dementia deficits in the ability to perform one or more basic activities of daily living

Exclusion Criteria:

* Non-English speaking patients and/or caregivers
* Subjects with a diagnosis of dementia due to conditions other than Alzheimer's disease.
* Subjects with a diagnosis of vascular dementia or a score greater than 4 on the modified Hachinski Ischemic Rating scale
* Patients with a major depressive disorder
* Patients with clinically significant laboratory abnormalities
* Patients receiving investigational pharmacologic agents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120874

Contacts
Contact: Sunnie Kenowsky, D.V.M. 212-263-7164 sunnie.kenowsky@med.nyu.edu
Contact: Thet Oo, M.D. 212-263-8088 thet.oo@med.nyu.edu

Locations
United States, New York
Fisher Alzheimer's Program, New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Sunnie Kenowsky, D.V.M. 212-263-7164 sunnie.kenowsky@med.nyu.edu
Contact: Thet Oo, M.D. 212-263-8088 thet.oo@med.nyu.edu

Sponsors and Collaborators
New York University School of Medicine
Forest Laboratories
Fisher Center for Alzheimer's Research Foundation

Investigators
Principal Investigator: Barry Reisberg, M.D. New York University School of Medicine
Study Director: Sunnie Kenowsky, D.V.M. New York University School of Medicine
More Information

Publications:
Reisberg B, Kenowsky S, Franssen EH, Auer SR, Souren LE. Towards a science of Alzheimer's disease management: a model based upon current knowledge of retrogenesis. Int Psychogeriatr. 1999 Mar;11(1):7-23.

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