Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm^2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive Decline

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00506415
• Date of registration: 20/07/2007
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm^2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive Decline
• Scientific title: A 48-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Evaluation of the Comparative Efficacy, Safety, and Tolerability of Exelon® 10 and 15 cm^2 Patch in Patients With Mild to Moderate Alzheimer's Disease (AD) Showing Functional and Cognitive Decline
• Date of first enrolment: June 2007
• Target sample size: 1584
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00506415
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Canada, France, Germany, Italy, Spain, Switzerland, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female patients between 50 and 85 years of age with a diagnosis of probable
Alzheimers Disease,

- Baseline Mini-Mental State Examination (MMSE) score 10-24 inclusive,

- A primary caregiver willing to accept responsibility for supervising treatment,
assessing the patient's condition throughout the study, and for providing input into
efficacy assessments.

- For double blind only: Meet the decline criteria of functional (as assessed by the
investigator) and cognitive (assessed by a 1 point reduction in Mini-Mental State
Examination) score between visits or a 3 point reduction from baseline) decline at
weeks 23, 36 or 48.

Exclusion Criteria:

- Presence of an advanced, severe, progressive, or unstable disease of any type that
could interfere with efficacy and safety assessments or put the patient at particular
risk,

- Any medical or neurological condition other than Alzheimers Disease that could explain
the patient's dementia,

- A diagnosis of probable or possible vascular dementia,

- A current diagnosis of unsuccessfully-treated depression, or any other mental disorder
that may interfere with the evaluation of the patient's response to study medication,

- A history or current diagnosis of cerebrovascular disease (e.g. stroke),

- A current diagnosis of severe or unstable cardiovascular disease (e.g. unstable
coronary artery disease).

Other protocol-defined inclusion/exclusion criteria may apply.



Age minimum: 50 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Alzheimer Disease

Intervention(s)

Drug: Placebo to 15 cm^2 patch

Drug: Placebo to 10 cm^2 patch

Drug: Rivastigmine 10 cm^2

Drug: Rivastigmine 15 cm^2

Drug: Rivastigmine 5 cm^2

Primary Outcome(s)

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) Subscale at Week 48 of Double Blind Period [Time Frame: Baseline and week 48 of double blind period]

Change in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) Subscale Score From Baseline to Week 48 of Double Blind Period [Time Frame: Baseline and week 48 of double blind period]

Secondary Outcome(s)

Change in Attention and Executive Function as Assessed by the Trail Making Test (Part A) at Week 48 of the Double Blind Period [Time Frame: Baseline and week 48 of double blind period]

Change From Baseline in Neuropsychiatric Inventory (NPI)-10 Score at Week 48 of Double Blind Period [Time Frame: Baseline and week 48 of double blind period]

Change in Attention and Executive Function as Assessed by the Trail Making Test (Part B) at Week 48 of Double Blind Period [Time Frame: Baseline and week 48 of double blind period]

Number of Patients With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events [Time Frame: 30 days after a maximum of 96 weeks treatment]

Time to Functional Decline as Measured by Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) Subscale During the Double Blind Period [Time Frame: 390 days was the maximum]

Secondary ID(s)

CENA713D2340

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/09/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00506415