NCT01399125

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
501

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

August 4, 2014

Completed
Last Updated

August 4, 2014

Status Verified

July 1, 2014

Enrollment Period

1.8 years

First QC Date

July 19, 2011

Results QC Date

May 5, 2014

Last Update Submit

July 10, 2014

Conditions

Alzheimer's Disease

Keywords

Alzheimer'sRivastigminePatchDementia

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline on Cognition, Assessed by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)

    The Alzheimer's Disease Assessment Scale (ADAS) is a performance-based test that measures specific cognitive and behavioral dysfunctions in patients with Alzheimer's Disease. The cognitive subscale of the ADAS (ADAS-Cog) comprises 11 items that are summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. It was assessed by a mental health professional (e.g., M.D., Ph.D., Pharm.D., R.N., or other equivalent qualifications) with a minimum of 2 years research experience meeting certification requirements.

    Change at 24 weeks

Secondary Outcomes (4)

  • Change From Baseline in Global Functioning, Assessed by the Alzheimer's Disease Assessment Scale Clinical Impression of Change (ADCS-CGIC)

    Change at 24 weeks

  • Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Total Score

    Change at 24 weeks

  • Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score

    Change at 24 weeks

  • Change From Baseline in Mini-Mental State Examination (MMSE) Total Score

    Change at 24 weeks

Study Arms (2)

Rivastigmine patch

EXPERIMENTAL

Once-daily target patch size 10 cm²

Drug: Rivastigmine PatchDrug: Placebo to Rivastigmine capsules

Rivastigmine capsules

ACTIVE COMPARATOR

Twice-daily target dose of 6 mg oral capsule

Drug: Rivastigmine CapsulesDrug: Placebo to Rivastigmine patch

Interventions

Rivastigmine PatchDRUG

Once-daily target patch size 10 cm²

Also known as: ENA713, Exelon
Rivastigmine patch
Rivastigmine CapsulesDRUG

Twice-daily target dose of 6 mg oral capsule

Also known as: ENA713, Exelon
Rivastigmine capsules
Placebo to Rivastigmine patchDRUG

Matching placebo to Rivastigmine patch

Also known as: placebo
Rivastigmine capsules
Placebo to Rivastigmine capsulesDRUG

matching Placebo to Rivastigmine capsules

Also known as: placebo
Rivastigmine patch

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Novartis Investigative Site

Fuzhou, Fujian, China

Location

Novartis Investigative Site

Wuhan, Hubei, 430022, China

Location

Novartis Investigative Site

Wuhan, Hubei, 430030, China

Location

Novartis Investigative Site

Nanjing, Jiangsu, 210029, China

Location

Novartis Investigative Site

Suzhou, Jiangsu, 215004, China

Location

Novartis Investigative Site

Changchun, Jilin, 130021, China

Location

Novartis Investigative Site

Shanghai, Shanghai Municipality, 200080, China

Location

Novartis Investigative Site

Xi’an, Shanxi, 710032, China

Location

Novartis Investigative Site

Chengdu, Sichuan, 610041, China

Location

Novartis Investigative Site

Hangzhou, Zhejiang, 310009, China

Location

Novartis Investigative Site

Beijing, 100028, China

Location

Novartis Investigative Site

Beijing, 100730, China

Location

Novartis Investigative Site

Shanghai, 200003, China

Location

Novartis Investigative Site

Shanghai, 200025, China

Location

Novartis Investigative Site

Shanghai, 200040, China

Location

Novartis Investigative Site

Shanghai, 200127, China

Location

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Interventions

Rivastigmine

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylcarbamatesCarbamatesAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
8627788300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2011

First Posted

July 21, 2011

Study Start

July 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

August 4, 2014

Results First Posted

August 4, 2014

Record last verified: 2014-07

Locations

CN(16)