Phase 4 N=20 Randomized Single-blind

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

Alzheimer's Disease

Bottom Line

View on ClinicalTrials.gov: NCT00120874 ↗

Enrolled (actual)

Serious AEs

65.0%

Results posted

Jul 2016

Primary outcome: Primary: Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version) — 2.3; 5.22 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Individualized management of AD including caregiver training (Behavioral); Memantine (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: NYU Langone Health
Primary completion: Nov 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)	2.1; 6	—
PRIMARY Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)	2.1; 6	—
PRIMARY Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)	18.5; 7.6	—
PRIMARY Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)	18.5; 7.6	—
SECONDARY Change From Baseline of the Severe Impairment Battery (SIB)	45.1; 48	—
SECONDARY Change From Baseline of the Severe Impairment Battery (SIB)	45.1; 48	—
SECONDARY Change From Baseline of the Mini-Mental State Examination (MMSE)	6.7; 6.7	—
SECONDARY Change From Baseline of the Mini-Mental State Examination (MMSE)	6.7; 6.7	—
SECONDARY Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)	6.5; 6.84	—
SECONDARY Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)	6.5; 6.84	—
SECONDARY Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)	8.1; 21.2	—
SECONDARY Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)	8.1; 21.2	—
SECONDARY Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency	24.4; 32.4	—
SECONDARY Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction	3.8; 11.4	—
SECONDARY Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency	24.4; 32.4	—
SECONDARY Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction	3.8; 11.4	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00120874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.