Phase 4
N=127
Corticolimbic Degeneration and Treatment of Dementia
Dementia
Bottom Line
View on ClinicalTrials.gov: NCT00768261 ↗Enrolled (actual)
127
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Rate of Change of Hippocampal Volume Slope — -70.2418748; -88.4738591; -94.0768115; -46.9484805 mm^3/year — p=0.095
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Memantine (Namenda®) (Drug); Donepezil (Aricept®) (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Change of Hippocampal Volume Slope |
-70.2418748; -88.4738591; -94.0768115; -46.9484805; -99.9437062; -94.3258652 | 0.095 |
| SECONDARY Comparison of Combined DAT Patients' Mean (SD) Hippocampal Volume Slope (mm^3/Year) Rate of Change |
-70; -106; -100; -77; -141; -105 | 0.066 |
Summary
The overall purpose of this research is to determine if there is a relationship between your symptoms of Dementia of the Alzheimers type and changes in the size and shape of certain brain structures during combined Donepezil (Aricept®) and Memantine (Namenda®) treatment.
Eligibility Criteria
Inclusion Criteria: 1) meets National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association(NINCDS-ADRDA) Alzheimer's criteria for dementia of the Alzheimer's type (DAT), 2) Clinical Dementia Rating (CDR) score of 0.5 or 1, 3) 50-80 years of age, 4) able to give informed consent or has a primary caregiver or legal guardian, who can give informed consent.
Exclusion Criteria: 1) other psychiatric (e.g., depression) or neurological (e.g., CVA) disorders that would confound the assessment of dementia symptoms, 2) history of loss of consciousness, and 3) unstable or severe medical illness (e.g., hepatotoxicity) that would make donepezil or memantine treatment or participation in other aspects of the study unsafe.
Data sourced from ClinicalTrials.gov (NCT00768261). 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.