Clinical trial NCT01399125: A 24-Week Efficacy, Safety and Tolerability of Rivastigmine Patch Study in Patients With Probable Alzheimer's Disease
Official title: A 24-Week, Randomized, Double-blind, Double-dummy, Parallel-group, Active-controlled Study to Assess the Efficacy, Safety, and Tolerability of the Once-daily Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (Mini-Mental State Examination (MMSE) 10-20)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: Alzheimer's
Rivastigmine
Patch
Dementia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-07-21
Enrollment: 501
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


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

Primary outcomes:
measure: Change From Baseline on Cognition, Assessed by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)
timeFrame: Change at 24 weeks
Secondary outcomes:
measure: Change From Baseline in Global Functioning, Assessed by the Alzheimer's Disease Assessment Scale Clinical Impression of Change (ADCS-CGIC)
timeFrame: Change at 24 weeks
measure: Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Total Score
timeFrame: Change at 24 weeks
measure: Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score
timeFrame: Change at 24 weeks
measure: Change From Baseline in Mini-Mental State Examination (MMSE) Total Score
timeFrame: Change at 24 weeks
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Novartis Investigative Site
state: Fujian
city: Wuhan
country: China
facility: Novartis Investigative Site
state: Hubei
city: Wuhan
country: China
facility: Novartis Investigative Site
state: Hubei
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Suzhou
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Changchun
country: China
facility: Novartis Investigative Site
state: Jilin
city: Shanghai
country: China
facility: Novartis Investigative Site
state: Shanghai
city: Xi'an
country: China
facility: Novartis Investigative Site
state: Shanxi
city: Chengdu
country: China
facility: Novartis Investigative Site
state: Sichuan
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: