CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 222 enrolled
Drug / intervention
ENA713drug
Likely dose
ENA713 1.5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01948791
NCT01948791Phase 4Completed
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16 Weeks Interventional Study on Titration and Dose/Efficacy Assessment of Exelon (Rivastigmine) in Chinese Alzheimer's Disease Patients (INSTINCT)

Novartis Pharmaceuticals·interventional·Posted Sep 24, 2013·Updated Feb 13, 2017

In Brief

A Phase 4 clinical trial evaluating ENA713 for Alzheimer's Disease. Completed, enrolled 222 participants across 1 site.

Detailed Summary

To investigate the efficacy of Exelon capsule at maximal tolerated dose in mild to moderate Chinese AD patients via dosage titration from 3mg/d to 12mg/d in a 16 weeks duration

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 24, 2013
Enrollment StartAug 1, 2014
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.8 years ago

Interventions

ENA713drug

The following strengths of Rivastigmine capsules were provided: Rivastigmine capsule strengths: 1.5mg, 3mg, 4.5mg. The 6mg dose was administered as one 1.5mg capsule and one 4.5mg capsule, and when necessary, the 3mg dose could also be administered as two 1.5mg capsules. Rivastigmine was administered from 3mg/d at baseline. Then dose escalation was made in 3mg/d increments, at a minimun of 4 weeks between dose increases to a maximum dose of 12mg/d or the individual's best tolerated dose.