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TerminatedNCT01143350Updated Jun 1, 2011

Non Pharmacological Treatment in Alzheimer's Disease and Associated Disorders

An interventional study of Bras A (EHPAD Training and stimulation) and EHPAD Control in Alzheimer's Disease, sponsored by Centre Hospitalier Universitaire de Nice. Terminated at 1 site in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2011-06-01.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
65 Years and older
Sex
All
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Study 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
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Conditions studied

  • Alzheimer's Disease

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In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 300 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Patients more than 65 years
  • MMSE score > 24
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    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.

    Other: Bras A (EHPAD Training and stimulation)

  • Placebo comparator
    2- EHPAD control

    EHPAD of the reference group, will have their habitual functioning

    Other: EHPAD Control

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

Secondary outcomes

  1. 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

    Time frame: 1 year

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Study locations

1 site
  • Robert
    Nice, Alpes-Maritimes 06001, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01143350
Lead sponsor
Centre Hospitalier Universitaire de Nice
First posted
Jun 14, 2010
Start date
Mar 2010
Primary completion
Mar 2010
Completion
Mar 2011
Last update
Jun 1, 2011

Study contacts

Philippe Ph ROBERT, PhD
principal investigator · CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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