Phase 3
Completed N=216
Randomized, Double-blind Study to Evaluate the Tolerability of 2 Different Titration Methods of Rivastigmine Patch in AD Patients (MMSE 10-20)
Source: ClinicalTrials.gov NCT01614886 ↗Enrolled (actual)
216
Serious AEs
8.8%
Results posted
May 2015
Primary outcomePrimary: Percentage of Patients With Adverse Events Leading to Study Drug Discontinuation — 15; 18.5 Percentage of participants
Summary
To evaluate the tolerability, safety and efficacy of 3-step titration versus 1-step titration of Rivastigmine patch in the Japanese population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Adverse Events Leading to Study Drug Discontinuation |
15; 18.5 | — |
| SECONDARY Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog) |
-1.3; -0.9; -1.6; -1.2; -1.6; -1.8 | — |
| SECONDARY Change From Baseline in Mini-Mental State Examination (MMSE) |
0.6; 0.5 | — |
| SECONDARY Number of Participants With Improvement in Japanese Clinical Global Impression of Change (J-CGIC). Patients With "Improvement": a Total of 1. Markedly Improved, 2. Improved, and 3. Slightly |
22; 23; 35; 26; 37; 33 | — |
| SECONDARY The Percentage of Treatment Retention. |
71; 69.4 | — |
Eligibility Criteria
Inclusion Criteria
- A diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria
- A clinical diagnosis of probable AD according to NINCDS/ADRDA criteria
- An MMSE score of ≥ 10 and ≤ 20 at baseline
Exclusion Criteria
- Any medical or neurological conditions other than AD that could explain the patient's dementia
- A current diagnosis of probable or possible vascular dementia
- A score of > 5 on the Modified Hachinski Ischemic Scale (MHIS)
- A current DSM-IV Axis 1 diagnosis that may interfere with the evaluation of the patient's response to study medication.
- Treated with donepezil or galantamine within last 4 weeks before the efficacy assessment at baseline.
- an advanced severe progressive or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient's at special risk
- Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01614886). 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.