Phase 4
Completed N=20
Memantine and Comprehensive, Individualized Management of Alzheimer's Disease and Caregiver Training
Source: ClinicalTrials.gov NCT00120874 ↗Enrolled (actual)
20
Serious AEs
65.0%
Results posted
Jul 2016
Primary outcomePrimary: 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
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 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 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 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 | — |
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
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. Informational only — not medical advice.