Non Pharmacological Treatment in Alzheimer's Disease and Associated Disorders

Alzheimer's Disease Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01143350
• Other study ID #: 09-PP-09
• Status: Terminated
• Phase: N/A
• First received: February 25, 2010
• Last updated: May 31, 2011
• Start date: March 2010
• Est. completion date: March 2011

Study information

• Verified date: March 2010
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Est. completion date: March 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Other:
• Bras A (EHPAD Training and stimulation)
EHPAD of the group of Training / Stimulation will benefit: after a training in behaviours to be held or in methods of stimulation aiming at the reduction of disturbances of behaviour at type of apathy. This information will be transmitted in l 'ensemble of l 'équipe of l 'EHPAD by a training officer. of a structuring of the activities of animation offered to the inhabitants, This information will be regrouped in chips worked out like TNM - EHPAD.
• EHPAD Control
EHPAD of the reference group, will have their habitual functioning

Locations

Country	Name	City	State
France	Robert	Nice	Alpes-Maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	No
Secondary	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	No