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Rivastigmine in the Management of Delirium

NCT01487317 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2016-07-20

No results posted yet for this study

Summary

The aim of this study is to evaluate the efficacy of an anticholinesterase treatment in patients aged 75 and over, hospitalized with delirium.

Study type : Interventional Study design: randomized, double-blind, placebo-controlled study during one month and a 11-month follow-up

Conditions

  • Delirium

Interventions

DRUG

Rivastigmine transdermal patch

One transdermal patch of Rivastigmine (equivalent to 4.6 mg/24h per os) per day from randomization to day 14 before day 14: end od treatment, if DRS R-98 severity \< 10 during 2 consecutive days At day 14, if DRS R-98 severity ≥ 10: one transdermal patch of Rivastigmine 9.5 mg/24h per day from day 14 to day 30 if DRS R-98 severity \< 10, the active treatment will be stopped

DRUG

placebo patch

One transdermal patch of placebo per day from randomization to day 14 Before day 14: end of treatment if DRS R-98 severity \< 10 during 2 consecutive days, At day 14 if DRS R-98 severity ≥ 10: One transdermal patch of placebo per day from day 14 to day 30 if DRS R-98 severity \< 10, the placebo treatment will be stopped

Sponsors & Collaborators

Principal Investigators

  • Marc Verny, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2015-08-31
Completion
2016-02-29

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01487317 on ClinicalTrials.gov