Phase 4
Completed N=62
Comparison of Once Daily and Twice Daily Dosing on Safety and Tolerability of Memantine in Patients With Alzheimer
Alzheimer Dementia (AD)
Source: ClinicalTrials.gov NCT02553928 ↗
Enrolled (actual)
62
Serious AEs
1.6%
Results posted
Mar 2019
Primary outcomePrimary: Adverse Events — 15; 16 Participants
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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
Evaluation of the safety and tolerability of a 20 mg once daily dose of memantine compared with 10 mg given twice daily in patients with dementia of Alzheimer's type and MMSE range 5-18.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
15; 16 | — |
| SECONDARY ADCS - CGIC Score at Week 12 |
3.92; 3.60 | 0.097 |
Eligibility Criteria
Inclusion Criteria
- The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinical visits during the study.
- The patient has a diagnosis of probable AD consistent with the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
- The patient has a Mini Mental State Examination (MMSE) score ≥ 5 and ≤ 18 at Screening visit
- The dose of Memantine has been stable at 20 mg once a day for at least 3 month prior to screening
Exclusion Criteria
- The patient has one or more of the following conditions: Evidence and/or history of any clinically significant neurodegenerative disease or other serious neurological disorders other than Alzheimer's disease including, but not limited to, Lewy body dementia, Fronto-Temporal dementia, Parkinson's disease, Huntington's disease, major cortical stroke, Multiple Sclerosis, major head trauma and primary or secondary cerebral neoplasm.
- The patient has a modified Hachinski ischemia score greater than 4 at the screening visit.
- The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than AD
- The patient is currently receiving treatment with an unstable dose of acetyl cholinesterase inhibitor
Other protocol defined inclusion and exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT02553928). 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.