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Non Pharmacological Treatment in Alzheimer's Disease and Associated Disorders

Primary Purpose

Alzheimer's Disease

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bras A (EHPAD Training and stimulation)
EHPAD Control
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alzheimer's Disease

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Robert

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

EHPAD Training and Stimulation

2- EHPAD control

Arm Description

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 of the reference group, will have their habitual functioning

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 25, 2010
Last Updated
May 31, 2011
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT01143350
Brief Title
Non Pharmacological Treatment in Alzheimer's Disease and Associated Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Terminated
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EHPAD Training and Stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
2- EHPAD control
Arm Type
Placebo Comparator
Arm Description
EHPAD of the reference group, will have their habitual functioning
Intervention Type
Other
Intervention Name(s)
Bras A (EHPAD Training and stimulation)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
EHPAD Control
Intervention Description
EHPAD of the reference group, will have their habitual functioning
Primary Outcome Measure Information:
Title
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.
Description
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Ph ROBERT, PhD
Organizational Affiliation
CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06001
Country
France

12. IPD Sharing Statement

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Non Pharmacological Treatment in Alzheimer's Disease and Associated Disorders

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