Non Pharmacological Treatment in Alzheimer's Disease and Associated Disorders

Centre Hospitalier Universitaire de Nice1 site in 1 country300 target enrollmentMarch 2010

ConditionsAlzheimer's Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Alzheimer's Disease
Sponsor: Centre Hospitalier Universitaire de Nice
Enrollment: 300
Locations: 1
Primary Endpoint: Identification of yet unknown enzymes involved in the processing of Ab, especially on those responsible for the exoproteasic truncation of Ab at its N-terminus.
Status: Terminated
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The STIM-EHPAD study (for stimulation in nursing home) aims to evaluate the short and medium term effectiveness of staff education as a non-pharmacological intervention to manage apathy in older people with a diagnosis of dementia.

Primary efficacy criteria: Apathy Inventory clinician score changes
Secondary efficacy criteria: Apathy Inventory patient and caregiver version changes, Observation scale changes, frequency and severity of the other BPSD using the NPI, qualitative analysis of the nursing home staff behavioural changes

Registry

clinicaltrials.gov

Start Date

March 2010

End Date

March 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Nice

Eligibility Criteria

Inclusion Criteria

•Patients older than 65 years
•A diagnosis of dementia according to the ICD 10 criteria
•MMSE score ≤ 24
•Presenting the diagnostic criteria of apathy (cf page ??)
•An Apathy Inventory clinician total score \>3 (with at least a score higher than 1 at one of the 3 dimensions; lack of initiative, lack of interest, emotional blunting)

Exclusion Criteria

•Patients more than 65 years
•MMSE score \> 24

Outcomes

Primary Outcomes

Identification of yet unknown enzymes involved in the processing of Ab, especially on those responsible for the exoproteasic truncation of Ab at its N-terminus.

Time Frame: 1 year

Identification of yet unknown enzymes involved in the processing of Ab, especially on those responsible for the exoproteasic truncation of Ab at its N-terminus.

Secondary Outcomes

Secondary efficacy criteria: Apathy Inventory patient and caregiver version changes, Observation scale changes, frequency and severity of the other BPSD using the NPI, qualitative analysis of the nursing home staff behavioural changes(1 year)