Phase 4
Completed N=264
Effect of Memantine on Functional Communication in Patients With Alzheimer's Disease
Source: ClinicalTrials.gov NCT00469456 ↗Enrolled (actual)
264
Serious AEs
6.4%
Results posted
Dec 2009
Primary outcomePrimary: Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12 — -0.6; 0.7 Units on a scale — p=0.070
Summary
The objective of this study is to evaluate the effect of memantine versus placebo on functional communication in patients with Alzheimer's Disease
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12 |
-0.6; 0.7 | 0.070 |
| SECONDARY Change From Baseline in American Speech-Language-Hearing Association Functional Assessment of Communication Skills for Adults (ASHA FACS) [Total Score of Social Communication and Communication of Basic Needs Subscores] at Week 12 |
-5.3; 0.5 | 0.022 sig |
Eligibility Criteria
Inclusion Criteria
- Male and female outpatients, 50 years or older, native English speakers, meeting National Institute of Neurological and Communicative Disorders and Stroke--Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable AD with a Mini Mental State Examination (MMSE) score of 10 to 19 at Screening and Baseline
Exclusion Criteria
- Current Diagnostic and Statistical Manual of Mental Disorders--Fourth Edition (DSM-IV) Axis I disorder other than AD
- Previous imaging results not consistent with the diagnosis of AD
- Modified Hachinski Ischemia Score greater than 4
- Evidence of other neurologic disorders
- Clinically significant systemic disease
- A known or suspected history of alcohol or drug abuse in the past 5 years
- Taking excluded medication
- Previous treatment with commercial memantine
Data sourced from ClinicalTrials.gov (NCT00469456). 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.