Phase 4
Completed N=127
Corticolimbic Degeneration and Treatment of Dementia
Source: ClinicalTrials.gov NCT00768261 ↗Enrolled (actual)
127
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcomePrimary: Rate of Change of Hippocampal Volume Slope — -70.2418748; -88.4738591; -94.0768115; -46.9484805 mm^3/year — p=0.095
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 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.
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 |
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. Informational only — not medical advice.