Rivastigmine in the Management of Delirium

NCT01487317 | Completed Phase 3 DMC

• 2 other identifiers: P0712442009-015632-15
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Delirium; acetylcholinesterase inhibitor; Elderly; Emergency department

Outcome Measures

Primary Outcomes (1)

• Hospital length of stay from randomization to declaration by investigator (MD) that patient can leave acute care

  to a maximum of 12 months

Secondary Outcomes (4)

• Percentage of patients with persistent delirium symptoms (DRS R-98 scale)

  at day 14

• Percentage of patients with persistent delirium symptoms (DRS R-98 scale)

  at day 30

• Percentage of patients with persistent delirium symptoms at day 30 (CAM scale)

  at day 30

• Percentage of patients with a dementia diagnosis at 12 months (according to the DSM IV criteria)

  at 12 months

Study Arms (2)

Rivastigmine transdermal patch

EXPERIMENTAL

Drug: Rivastigmine transdermal patch

placebo

PLACEBO COMPARATOR

Drug: placebo patch

Interventions

Rivastigmine transdermal patch DRUG

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

Rivastigmine transdermal patch

placebo patch DRUG

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

placebo

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients aged 75 and over
• Hospitalization for delirium not correlated to surgery for less than 48 hours
• Patients with delirium requiring the presence of features 1 (acute onset and fluctuation course), 2 (inattention), 3 (disorganized thinking) and 4 (altered level of consciousness) of the Confusion Assessment Model and DRS R-98 \> 10
• Absence of any contraindications to a cholinesterase inhibitor treatment
• Health insurance affiliation
• Having signed an informed consent form
• Caregiver/informant to provide information on patient

You may not qualify if:

• Use of IAchE or memantine medication
• Contraindication to IAchE medication
• Frontotemporal dementia
• Diseases involving the short-term survival
• Digestive bleeding
• Ischemic and hemorrhagic stroke related to actual onset (including hemorrhagic contusion)
• Natremia ≤120 mmol/l at the time of hospitalization
• Post epileptic confusion
• Hepato-cellular failure
• Cardiorespiratory impairment at risk of transfer to intensive care unit
• Major sensory deficits that could interfere with cognitive assessment (visual and auditory)
• Not fluent in French
• Being under guardianship
• Absence of caregiver/informant to sign informed consent form

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Pitié Salpetriere Hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

Delirium; Emergencies

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes

Study Officials

• Marc Verny, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 7, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: February 1, 2016
• Last Updated: July 20, 2016

Record last verified: 2016-07

Locations

FR (1)