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Non Pharmacological Treatment in Alzheimer's Disease and Associated Disorders

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01143350
Enrollment
300
Registered
2010-06-14
Start date
2010-03-31
Completion date
2011-03-31
Last updated
2011-06-01

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

Conditions

Alzheimer's Disease

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

Interventions

OTHERBras 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.

OTHEREHPAD Control

EHPAD of the reference group, will have their habitual functioning

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 yearIdentification 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

MeasureTime frame
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 changes1 year

Countries

France

Outcome results

None listed

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