Alzheimer DiseasePACONCT01297140
The PACO Study ("Personnalité Alzheimer COmportement")
A study testing questioning in people with Alzheimer Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Alzheimer's disease is characterised by a loss of cognitive functions and behavioural problems as set out under the term "Behavioural and psychological symptoms of dementia (BPSD)". The impact of BPSD in everyday life has heavy consequences for the patient and their family. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- questioning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject aged over 50 years ;
- In-patient or out-patient at one of the centres participating in the study ;
- Meeting all the diagnostic criteria for dementia due to AD (NINCDS ADRDA, CDR 1 or 2) or pre-dementia with a CDR of 0.5 (Berr et al., 2006, Dubois et al, 2007) ;
- Covered by the state's Social Security system ;
- With sufficient visual, auditory and oral and written French language skills to complete the clinical and neuropsychological evaluations ;
- Accompanied by a caregiver in sufficient contact with the subject to be able to assess their personality and note the onset of changes in behaviour.
Who cannot join
- Patients with a progressive and/or poorly managed psychiatric pathology (patients with stabilised depression could be included in the study) ;
- Patients taking any neuroleptic psychotropic medication ;
- Patients taking other psychotropic medication, with the exception of any antidepressant, hypnotic, anxiolytic, acetylcholinesterase inhibitors or Memantine which has been prescribed and stabilised for more than 3 months
- Patients with forms of dementia with an aetiology other than that of Alzheimer's disease (frontotemporal dementia, vascular dementia, Lewy Body dementia, and types of dementia that arise as a result of an underlying untreated disease, such as dysthyroidism, vitamin B12 or folic acid deficiency, syphilis, anaemia or hydroelectrolytic disorders) ;
- Patients with serious, progressive or unstable pathologies which could interfere with the variables under consideration ;
- Deafness or blindness which could compromise evaluation of the patient ;
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- Pregnancy ;
- Patients under any type of guardianship or belonging to a restricted category as laid out in the Public Health Code ;
- Patients without a suitable caregiver willing to participate.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Gériatrie - Hôpital des Charpennes - Hospices Civils de Lyon
Villeurbanne, 69100
Pierre KROLAK-SALMON, Professor, 04.72.43.31.13, pierre.krolak-salmon@chu-lyon.fr
Pierre KROLAK-SALMON, Professor
About this study
Official title: The Role of Personality in the Occurrence of Behavioural Disorders in Patients Suffering From Alzheimer Disease
Alzheimer's disease is characterised by a loss of cognitive functions and behavioural problems as set out under the term "Behavioural and psychological symptoms of dementia (BPSD)". The impact of BPSD in everyday life has heavy consequences for the patient and their family. The precocity of incidence, the frequency and the intensity of the BPSD are associated with a rapid decline in cognitive functions, an alteration in the activities of daily living, and a decrease in the quality of life for both the patient and the helper, an increased risk of hospitalisation and of institutionalisation as well as an increase in the cost to the health system. A greater understanding of the risk factors for the occurence of the BPSD would better allow the detection of patients who are particularly at risk for BPSD, to anticipate the crisis situations by proposing early and adapted care, and to better target the medicinal therapies. Certain observational arguments or results of retrospective studies speak in favour of the role of the basic personality in the occurence of BPSD in Alzheimer's disease. The investigators propose to clarify this role through a prospective study.
- Conditions
- Alzheimer Disease
- Being tested
- questioning
- Keywords
- Psychiatry, Behaviour, Alzheimer's, Personality
- Medical subject headings
- Alzheimer Disease, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questioningBehavioural
Patients will be screened by questioning them and their caregiver and from the results of the clinical examination and the biological and neuroradiological tests habitually carried out in cases of dementia and following accepted procedures.
| Study group | Role | What they receive |
|---|---|---|
| questionary | Experimental | Not described Receives: Behavioral: questioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioural and psychological symptoms of dementia (BPSD)
To measure (at inclusion, and at 6, 12, 18 months) the effect of premorbid personality and life events on the likelihood of a patient with probable Alzheimer's disease being affected by each of the BPSD categories: hyperactivity, psychotic symptoms, mood symptoms and apathy.
Measured: 18 months
Secondary outcomes (3)
social cognition tests
To evaluate, at the time of inclusion, the connection between the basic personality and the performance in social cognition tests (capacity to interact with others)
Measured: during the inclusion visit
connection between social cognitive tests and BPSD
To evaluate (at inclusion and after 6, 12, 18 months) the connection between the performance of the social cognitive tests at the time of inclusion and the risks of occurrence of BPSD.
Measured: 18 months
connection between cerebral atrophy and BPSD
To evaluate the connection between the distribution of regional cerebral atrophy, determined by a MRI at the time of inclusion, and the risk of subsequent BPSD.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startJan 2009
- Primary completionJul 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297140
- Sponsor's protocol ID
- 2008.508
- Acronym
- PACO
- Status last verified
- Oct 2014
- First submitted
- 14 Feb 2011
- Last updated
- 3 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Rouch I, Dorey JM, Boublay N, Henaff MA, Dibie-Racoupeau F, Makaroff Z, Harston S, Benoit M, Barrellon MO, Federico D, Laurent B, Padovan C, Krolak-Salmon P; PACO group. Personality, Alzheimer's disease and behavioural and cognitive symptoms of dementia: the PACO prospective cohort study protocol. BMC Geriatr. 2014 Oct 10;14:110. doi: 10.1186/1471-2318-14-110.
PubMed 25304446
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Personality in the Occurrence of Behavioural Disorders in Patients Suffering From Alzheimer Disease
- ClinicalTrials.gov ID
- NCT01297140
- Acronym / sponsor ID
- PACO / 2008.508
- Conditions
- Alzheimer Disease
- Keywords
- Psychiatry, Behaviour, Alzheimer's, Personality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 16 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alzheimer's disease is characterised by a loss of cognitive functions and behavioural problems as set out under the term "Behavioural and psychological symptoms of dementia (BPSD)". The impact of BPSD in everyday life has heavy consequences for the patient and their family. The precocity of incidence, the frequency and the intensity of the BPSD are associated with a rapid decline in cognitive functions, an alteration in the activities of daily living, and a decrease in the quality of life for both the patient and the helper, an increased risk of hospitalisation and of institutionalisation as well as an increase in the cost to the health system. A greater understanding of the risk factors for the occurence of the BPSD would better allow the detection of patients who are particularly at risk for BPSD, to anticipate the crisis situations by proposing early and adapted care, and to better target the medicinal therapies. Certain observational arguments or results of retrospective studies speak in favour of the role of the basic personality in the occurence of BPSD in Alzheimer's disease. The investigators propose to clarify this role through a prospective study.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| questionary | Experimental | Behavioral: questioning |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subject aged over 50 years ;
- In-patient or out-patient at one of the centres participating in the study ;
- Meeting all the diagnostic criteria for dementia due to AD (NINCDS ADRDA, CDR 1 or 2) or pre-dementia with a CDR of 0.5 (Berr et al., 2006, Dubois et al, 2007) ;
- Covered by the state's Social Security system ;
- With sufficient visual, auditory and oral and written French language skills to complete the clinical and neuropsychological evaluations ;
Key exclusion criteria (9 listed)
- Patients with a progressive and/or poorly managed psychiatric pathology (patients with stabilised depression could be included in the study) ;
- Patients taking any neuroleptic psychotropic medication ;
- Patients taking other psychotropic medication, with the exception of any antidepressant, hypnotic, anxiolytic, acetylcholinesterase inhibitors or Memantine which has been prescribed and stabilised for more than 3 months
- Patients with forms of dementia with an aetiology other than that of Alzheimer's disease (frontotemporal dementia, vascular dementia, Lewy Body dementia, and types of dementia that arise as a result of an underlying untreated disease, such as dysthyroidism, vitamin B12 or folic acid deficiency, syphilis, anaemia or hydroelectrolytic disorders) ;
- Patients with serious, progressive or unstable pathologies which could interfere with the variables under consideration ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questioningPatients will be screened by questioning them and their caregiver and from the results of the clinical examination and the biological and neuroradiological tests habitually carried out in cases of dementia and following accepted procedures. | Behavioural | questionary |
Primary outcome
Behavioural and psychological symptoms of dementia (BPSD)
Time frame: 18 months
To measure (at inclusion, and at 6, 12, 18 months) the effect of premorbid personality and life events on the likelihood of a patient with probable Alzheimer's disease being affected by each of the BPSD categories: hyperactivity, psychotic symptoms, mood symptoms and apathy.
3 secondary outcomes
social cognition tests
Time frame: during the inclusion visit
connection between social cognitive tests and BPSD
Time frame: 18 months
connection between cerebral atrophy and BPSD
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2014.
- Derived from this study: PubMed 25304446Rouch I, Dorey JM, Boublay N, Henaff MA, Dibie-Racoupeau F, Makaroff Z, Harston S, Benoit M, Barrellon MO, Federico D, Laurent B, Padovan C, Krolak-Salmon P; PACO group. Personality, Alzheimer's disease and behavioural and cognitive symptoms of dementia: the PACO prospective cohort study protocol. BMC Geriatr. 2014 Oct 10;14:110. doi: 10.1186/1471-2318-14-110.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questioning in people with Alzheimer Disease, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre KROLAK-SALMON, Professor (04.72.43.31.13, pierre.krolak-salmon@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioural and psychological symptoms of dementia (BPSD) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01297140, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2014.