Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury and Cognitive Impairment

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00171795

Enrollment

Registered

2005-09-15

Start date

2002-11-30

Completion date

2005-05-31

Last updated

2011-11-23

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

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injury,, cognitive impairment,, rivastigmine

Brief summary

This study is designed to investigate the efficacy and safety of rivastigmine compared with placebo in patients with traumatic brain injury and cognitive impairment.

Interventions

DRUGRivastigmine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Inclusion criteria

* Traumatic brain injury confirmed by available brain imaging (CT or MRI) and be at least 52 weeks post injury * Neuropsychologic disturbances indicated by: impaired memory (reduction of below 1 standard deviation (SD) of the mean on the California Verbal Learning Test (CVLT) and impaired executive function (reduction of below 1 standard deviation (SD) of the mean on the Verbal Memory Learning Test (VLMT) and Tower of London Test (ToL) and impaired attention (reduction of below 1 standard deviation (SD) of the mean on the Test Battery for Attentional Performance (TAP) * Be required to have had sufficient education to read, write, and effectively communicate * Be cooperative, able to ingest oral medication, and able to complete all aspects of the study and capable of doing so, either alone or with the aid of a responsible caregiver according to the investigator's judgement

Exclusion criteria

* A current diagnosis of cerebrovascular disease, any primary neurodegenerative disorder, or any other causes of neuropsychologic disturbances * A current diagnosis of active, uncontrolled seizure disorder or major depression, or any other diagnosis that may interfere with the patient's response to study medication * An advanced, severe or unstable disease of any type that may interfere with efficacy evaluations * Female patients with child-bearing potential who are breast-feeding, pregnant or not practicing non-hormonal contraception Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
20 week's treatment with rivastigmine on selective attention compared with placebo in patients with TBI and cognitive impairment	—

Secondary

Measure	Time frame
Safety of rivastigmine	—
Change from baseline to week 20 in cognitive functioning including selective attention, memory, executive function, and global clinical rating	—

Outcome results

None listed

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