Phase 3
Completed N=501
A 24-Week Efficacy, Safety and Tolerability of Rivastigmine Patch Study in Patients With Probable Alzheimer's Disease
Source: ClinicalTrials.gov NCT01399125 ↗Enrolled (actual)
501
Serious AEs
7.4%
Results posted
Aug 2014
Primary outcomePrimary: Change From Baseline on Cognition, Assessed by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) — -0.5; -0.7 Scores on a scale
Summary
The purpose of this study is to assess the efficacy, safety, and tolerability of Exelon® patch in patients with probable AD (MMSE 10-20), in order to support a planned regulatory submission and registration of Exelon transdermal patch in China. The study is designed to confirm the non-inferiority of the efficacy of Exelon patch (target 10 cm² patch size) versus Exelon capsules (target 6.0 mg bid dose) on cognition, using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline on Cognition, Assessed by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) |
-0.5; -0.7 | — |
| SECONDARY Change From Baseline in Global Functioning, Assessed by the Alzheimer's Disease Assessment Scale Clinical Impression of Change (ADCS-CGIC) |
1; 1; 10; 12; 68; 59 | — |
| SECONDARY Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Total Score |
-1.9; -1.7 | — |
| SECONDARY Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score |
-1.3; -1.3; -1.2; -1.3; -0.4; -0.6 | — |
| SECONDARY Change From Baseline in Mini-Mental State Examination (MMSE) Total Score |
0.7; 0.7 | — |
Eligibility Criteria
Inclusion criteria
- have a diagnosis of dementia of the Alzheimer's type according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria;
- have a clinical diagnosis of probable AD according to NINCDS/ADRDA criteria.
- have a brain scan (magnetic resonance imaging (MRI) or computed tomography (CT)) consistent with the diagnosis of AD. The brain scan must have been performed within one year prior to randomization;
- have an MMSE score of ≥ 10 and ≤ 20;
- have sufficient education to have been able to read, write, and communicate effectively during the premorbid state;
- be residing with someone in the community throughout the study or, if living alone, in contact with the primary caregiver everyday;
Exclusion criteria
- have an advanced, severe, progressive, or unstable infectious, metabolic, immune, endocrinologic, hepatic, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological condition that may interfere with efficacy and safety assessments or put the patient at special risk;
- have a history or current diagnosis of any medical or neurological condition other than AD that is identified as contributing cause of the patient's dementia;
- have a current diagnosis of probable or possible vascular dementia according to the National Institute of Neurological Disorders and Stroke and the Association Internationale pour la Recherche et l'Enseignement en Neurosciences criteria (NINDS-AIREN);
- have a score of > 4 on the Modified Hachinski Ischemic Scale (MHIS);
- have a current DSM-IV diagnosis of major depression, unless, in the opinion of the investigator, is in remission for at least 12 weeks;
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01399125). 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.