Non Pharmacological Treatment in Alzheimer's Disease and Associated Disorders

Not Applicable

Terminated

• Conditions: Alzheimer's Disease

• Registration Number: NCT01143350
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-25
• Status Verified: 2010-03
• Study Start: 2010-03
• Primary Completion: 2010-03
• Study First Submitted QC: 2010-06-11
• Study First Posted: 2010-06-14
• Study Completion: 2011-03
• Last Update Submitted: 2011-05-31
• Last Update Posted: 2011-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Robert; 🇫🇷 Nice, Alpes-Maritimes, France