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

Information source: New York University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alzheimer's Disease

Intervention: Individualized management of AD including caregiver training (Behavioral); Memantine (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: New York University School of Medicine

Official(s) and/or principal investigator(s):
Barry Reisberg, M.D., Principal Investigator, Affiliation: New York University School of Medicine
Sunnie Kenowsky, D.V.M., Study Director, Affiliation: New York University School of Medicine


The purpose of this study is to determine whether a comprehensive, individualized management approach with caregiver training and medication with memantine will alleviate symptoms in community dwelling patients with moderate to severe Alzheimer's disease.

Clinical Details

Official title: Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Primary outcome:

Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) global score at baseline, 4, 12,28 and 52 weeks

the changes from baseline to weeks 28 & 52 in the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory modified for severe dementia (ADCS-ADLsev) assessed at 0, 4, 12, 28 weeks.

Secondary outcome:

Severe Impairment Battery

Mini-Mental State Examination

Functional Assessment Staging

Global Deterioration Scale

Behavioral Pathology in Alzheimer's Disease-Frequency Weighted

Memory and Behavior Problems Checklist

All secondary outcomes scored at baseline, 4, 12, and 28 weeks

Detailed description: 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. Patients are randomly placed into one of two groups. Both groups receive memantine and comprehensive evaluations at baseline, 4, 12,28 and 52 weeks. Additionally, group 1 receives an individualized management program, which consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.


Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Locations and Contacts

Fisher Alzheimer's Program, New York University School of Medicine, New York, New York 10016, United States
Additional Information

Related 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.

Teri L, Gibbons LE, McCurry SM, Logsdon RG, Buchner DM, Barlow WE, Kukull WA, LaCroix AZ, McCormick W, Larson EB. Exercise plus behavioral management in patients with Alzheimer disease: a randomized controlled trial. JAMA. 2003 Oct 15;290(15):2015-22.

Starting date: August 2006
Last updated: September 4, 2014

Page last updated: August 23, 2015

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