An Open-label Extension to Evaluate the Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00219232

Enrollment

868

Registered

2005-09-22

Start date

2003-02-28

Completion date

2006-07-31

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease, Dementia

Brief summary

The goal of this research study is to evaluate, in the open-label extension phase, the safety and efficacy of the rivastigmine transdermal patch in patients with probable Alzheimer's Disease

Interventions

DRUGRivastigmine Transdermal Patch

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Patients who fulfilled the inclusion and

Exclusion criteria

as listed in the study CENA713D2320 and have completed the double-blind treatment phase on study medication without significant protocol violations.

Design outcomes

Primary

Measure	Time frame
Safety and tolerability as measured by adverse events, vital signs and skin irritation for up to 28 weeks treatment	—

Secondary

Measure	Time frame
Change in cognition from baseline (week 24 of the double blind phase) at week 52	—
Clinical global impression of change from baseline at week 52	—
Change in activities of daily living from baseline at week 52	—
Change in behavioral symptoms from baseline at week 52	—
Change in executive function from baseline at week 52	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026