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NCT00948766 · ClinicalTrials.gov registry record · Phase 4

Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type (ACTION) (Study Protocol CENA713DUS44, NCT00948766) and a 24 Week Open-label Extension to Study CENA713DUS44

A Phase 4 study, sponsored by Novartis.

Completed
Registry status
Phase 4
Development phase
716
Enrollment target

NCT00948766: Completed Phase 4 study, sponsored by Novartis.

NCT00948766 is a Phase 4 study that has completed, run by Novartis. The registered enrollment target is 716 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00948766, a Phase 4 study, has completed, sponsored by Novartis.

COMPLETED
Registry status
Phase 4
Development phase
716 participants
Enrollment target

Study Summary

The core study assessed the efficacy of a higher dose of rivastigmine 13.3 mg/24 h transdermally (15 cm\^2 patch) compared to a lower dose of the rivastigmine 4.6 mg/24 h transdermally (5 cm\^2 patch) in patients with Severe Dementia of the Alzheimer's Type in a 24-week study. The extension study obtained additional safety and efficacy data, as well as provided the higher dose rivastigmine patch to all patients who completed the core study for an additional 24 weeks.

Primary Outcome

The ADCS-ADL-SIV is designed to assess the patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, and making judgments and decisions. For each of the 19 questions in the ADCS-ADL-SIV, there was either a forced choice of best response or a "yes" or "no" question with additional sub-questions. Responses for each item were ob

Interventions

  • DRUG Placebo
  • DRUG Rivastigmine 4.6 mg/24 h (5 cm^2)
  • DRUG Rivastigmine 9.5 mg/24 h (10 cm^2)
  • DRUG Rivastigmine 13.3 mg/24 h (15 cm^2)

Trial Details

FieldValue
Enrollment Target 716 participants
Start Date 2009-07
Est. Completion 2012-06
Phase Phase 4
Novartis

265 total trials

What the finished NCT00948766 record still lists

NCT00948766 is an interventional study that assigns participants to a tested intervention. The registered 716 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (38% higher).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT00948766 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00948766 about?

NCT00948766 is a clinical study titled "Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type (ACTION) (Study Protocol CENA713DUS44, NCT00948766) and a 24 Week Open-label Extension to Study CENA713DUS44". The core study assessed the efficacy of a higher dose of rivastigmine 13.3 mg/24 h transdermally (15 cm\^2 patch) compared to a lower dose of the rivastigmine 4.6 mg/24 h transdermally (5 cm\^2 patch) in patients with Severe Dementia of the Alzheimer's Type in a 24-week study. The extension study ob...

What is the current status of trial NCT00948766?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 716 participants. The study started on 2009-07. Estimated completion is 2012-06.

What interventions are being tested in trial NCT00948766?

The interventions under investigation include: Placebo (DRUG), Rivastigmine 4.6 mg/24 h (5 cm^2) (DRUG), Rivastigmine 9.5 mg/24 h (10 cm^2) (DRUG), Rivastigmine 13.3 mg/24 h (15 cm^2) (DRUG).

Who is sponsoring clinical trial NCT00948766?

This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00948766's enrollment target sits among peer trials

716 114th of 2000 higher than 1,887 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00948766, the US trial registry maintained by the National Library of Medicine. NCT00948766 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.