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

NCT00120874 | Completed Phase 4 Results DMC

• 2 other identifiers: H12444-01 ANAM MD 18
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease; caregiver training; caregiver counseling; individualized management; memantine; dementia

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)

  CIBIC-Plus is measured in units on a scale ranging from 1 to 7, where 1 is markedly improved, 4 is unchanged, and 7 is markedly worse

  Baseline to 28 weeks

• Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)

  CIBIC-Plus is measured in units on a scale ranging from 1 to 7, where 1 is markedly improved, 4 is unchanged, and 7 is markedly worse

  Baseline to 52 weeks

• Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)

  The ADCS-ADLsev-abv is a structured questionnaire where each item consists of a series of hierarchical questions designed to determine a patient's ability to perform the activities of daily living as assessed by the caregiver. Possible scores range from 0 to 39, where a higher score is indicative of greater capacities.

  Baseline to 28 weeks

• Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)

  The ADCS-ADLsev-abv is a structured questionnaire where each item consists of a series of hierarchical questions designed to determine a patient's ability to perform the activities of daily living as assessed by the caregiver. Possible scores range from 0 to 39, where a higher score is indicative of greater capacities.

  Baseline to 52 weeks

Secondary Outcomes (12)

• Change From Baseline of the Severe Impairment Battery (SIB)

  Baseline to 28 weeks

• Change From Baseline of the Severe Impairment Battery (SIB)

  Baseline to 52 weeks

• Change From Baseline of the Mini-Mental State Examination (MMSE)

  Baseline to 28 weeks

• Change From Baseline of the Mini-Mental State Examination (MMSE)

  Baseline to 52 weeks

• Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)

  Baseline to 28 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Individualized Management including caregiver training and Memantine

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

Group 2

ACTIVE COMPARATOR

Only Memantine

Drug: Memantine

Interventions

Individualized management of AD including caregiver training BEHAVIORAL

Individualized management program: 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.

Also known as: Namenda, Activity therapy, Cognitive stimulation therapy, Exercise, Caregiver support, Alzheimer's, Alzheimer's Disease

Group 1

Memantine DRUG

Patients receive 10 milligrams of memantine twice daily.

Also known as: Namenda

Group 1; Group 2

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Forest Laboratories: collaborator
• Fisher Center for Alzheimer's Research Foundation: collaborator

Study Sites (1)

Fisher Alzheimer's Program, New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (2)

• 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. doi: 10.1017/s1041610299005554.

  PMID: 10189596 BACKGROUND

• 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. doi: 10.1001/jama.290.15.2015.

  PMID: 14559955 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Interventions

Memantine; Exercise; Amyloid beta-Protein Precursor

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Amyloidogenic Proteins; Amyloid; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Protein Precursors; Protease Nexins; Proteinase Inhibitory Proteins, Secretory

Limitations and Caveats

The original statistician who worked on this study left the institution prior to completing data analysis. A new statistician has been engaged. In the unlikely event that outcome measures data changes, it will be updated accordingly in this record.

Results Point of Contact

• Title: Barry Reisberg
• Organization: NYU Langone Medical Center

barry.reisberg@nyumc.org

121-263-8550

Study Officials

• Barry Reisberg, M.D.

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Sunnie Kenowsky, D.V.M.

  NYU Langone Health

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2005
• First Posted: July 19, 2005
• Study Start: August 1, 2006
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: October 25, 2016
• Results First Posted: July 14, 2016

Record last verified: 2016-09

Locations

US (1)