- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04254094
A Cohort Study of Early Onset Neurodegenerative Dementias Prognostic Factors (NEODEM)
Study of Behavioural and Psychological Symptoms as Functional Prognostic Factors in Neurodegenerative Early Onset Major Neurocognitive Disorders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Early-onset dementia (EOD), which begins before the age of 65, is less common than late-onset dementia but represents a significant burden for the patient, their family and the healthcare system. The descriptive epidemiology is poorly known, and the National Reference Center for young patients, using English data (Harvey et al., 2003) estimates the number of subjects concerned in France at 18,318. It is degenerative dementia that is the most common cause of EOD and among them, Alzheimer's disease and then frontotemporal degeneration (FTD) (Vieira et al., 2013). The natural history and prognostic factors of PDD are not well known, and only AD has some data. Alzheimer's disease (AD) in young people appears to have a worse prognosis than that in older people, but this is debated (Stanley and Walker, 2014) and also depends on the criteria studied: cognition, function or survival. Prognostic factors other EOD, and in particular frontotemporal dementias, which moreover are heterogeneous pathologies, are even less known.
Investigators have chosen to study the functional prognosis of patients because it is both very relevant to care needs and easy to measure. Among the prognostic factors of functional status, investigators will study in particular psycho-behavioral disorders, and in particular depression, which is very common in patients with EOD, a factor of poor quality of life and accessible to treatment. Other potential prognostic factors such as cognitive reserve, gender, clinical variants of AD and DFT, family status (living alone or having a caregiver), genetic status, family history of dementia, CSF biomarkers and MRI imaging will be studied . The evolution of instrumental activities of daily living will be measured. The social and paramedical resources used by the patient and his family will be collected, as well as the use of psychotropic and non-drug treatments. Finally, the overall evolution of the severity of dementia will be measured.
Eligible patients will be included for 3 years and evaluated every 6 months.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Sophie AURIACOMBE, M.D
- Phone Number: 33(0)5 57 82 01 16
- Email: sophie.auriacombe@u-bordeaux.fr
Study Locations
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Bordeaux, France, 33076
- CHU de Bordeaux
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Newly diagnosed neurodegenerative (within 6 months) EOD according to international consensus criteria
- Symptoms onset before 65 years old
- Clinical Dementia Rating Scale (CDR) 0.5 to 1 both inclusive
- Affiliated person or beneficiary of a social security scheme.
- Free and informed consent obtained and signed by the patient or by the patient's representative and a non-opposition letter signed by the caregiver when available
- Able to participate to cognitive and psychiatric assessments
Exclusion Criteria:
- Non degenerative dementias : e;g. vascular, alcohol-related, toxic, infectious, posttraumatic.
- Dementia of unknown etiology
- Dementia in Down syndrome
- Patients in Nursing Home or other care facility
- Total dependency for dressing and/or bathing at the time of inclusion
Patient with a severe or life-threatening disease
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Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Early onset dementias (EOD)
Prospective multicenter cohort of EOD patients with a three-year follow-up in tertiary Reference Memory centers
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Basic Activity of Daily Living (BADL) and Instrumental Activities of Daily Living (IADL), Neuropsychiatric Inventory (NPI), Cornell Scale for Depression in Dementia (CSDD), Clinical Dementia Rating Scale (CDR) and defining dementia criteria.
Also as part of this study, an MRI examination at baseline and at 18 months follow-up will be performed in the Bordeaux center
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BADL dependency in both bathing and dressing using the BADL scale from Katz (Katz et al., 1970) at inclusion
Time Frame: at inclusion
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Katz scale ranks the adequacy of performance in six basic functions including bathing, dressing, toileting, transferring,continence, and feeding..
It has been shown that bathing and dressing are the first ADL to be lost, also defined by Katz et al. as the thresholds for disability (Katz et al., 1970 ; Edjolo et al., 2016).
Each item is graded according to the level of dependence as follows: performs independently (0 point), performs with assistance (1 point), and unable to perform (2 point).
A total score of 0 indicates "full function" and 12 indicates "severe functional impairment".
To evaluate the primary outcome, only the score at the two first items (bathing and dressing, scoring from 0 to 4) will be taken into account for the analysis: complete dependency is present if the score at the two first items is 4 and absent if <4.
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at inclusion
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BADL dependency in both bathing and dressing using the BADL scale from Katz (Katz et al., 1970) at 6 months
Time Frame: 6 months after inclusion
|
Katz scale ranks the adequacy of performance in six basic functions including bathing, dressing, toileting, transferring,continence, and feeding..
It has been shown that bathing and dressing are the first ADL to be lost, also defined by Katz et al. as the thresholds for disability (Katz et al., 1970 ; Edjolo et al., 2016).
Each item is graded according to the level of dependence as follows: performs independently (0 point), performs with assistance (1 point), and unable to perform (2 point).
A total score of 0 indicates "full function" and 12 indicates "severe functional impairment".
To evaluate the primary outcome, only the score at the two first items (bathing and dressing, scoring from 0 to 4) will be taken into account for the analysis: complete dependency is present if the score at the two first items is 4 and absent if <4.
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6 months after inclusion
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BADL dependency in both bathing and dressing at 12 months
Time Frame: 12 months after inclusion
|
Katz scale ranks the adequacy of performance in six basic functions including bathing, dressing, toileting, transferring,continence, and feeding..
It has been shown that bathing and dressing are the first ADL to be lost, also defined by Katz et al. as the thresholds for disability (Katz et al., 1970 ; Edjolo et al., 2016).
Each item is graded according to the level of dependence as follows: performs independently (0 point), performs with assistance (1 point), and unable to perform (2 point).
A total score of 0 indicates "full function" and 12 indicates "severe functional impairment".
To evaluate the primary outcome, only the score at the two first items (bathing and dressing, scoring from 0 to 4) will be taken into account for the analysis: complete dependency is present if the score at the two first items is 4 and absent if <4.
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12 months after inclusion
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BADL dependency in both bathing and dressing at 18 months
Time Frame: 18 months after inclusion
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Katz scale ranks the adequacy of performance in six basic functions including bathing, dressing, toileting, transferring,continence, and feeding..
It has been shown that bathing and dressing are the first ADL to be lost, also defined by Katz et al. as the thresholds for disability (Katz et al., 1970 ; Edjolo et al., 2016).
Each item is graded according to the level of dependence as follows: performs independently (0 point), performs with assistance (1 point), and unable to perform (2 point).
A total score of 0 indicates "full function" and 12 indicates "severe functional impairment".
To evaluate the primary outcome, only the score at the two first items (bathing and dressing, scoring from 0 to 4) will be taken into account for the analysis: complete dependency is present if the score at the two first items is 4 and absent if <4.
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18 months after inclusion
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BADL dependency in both bathing and dressing at 24 months
Time Frame: 24 months after inclusion
|
Katz scale ranks the adequacy of performance in six basic functions including bathing, dressing, toileting, transferring,continence, and feeding..
It has been shown that bathing and dressing are the first ADL to be lost, also defined by Katz et al. as the thresholds for disability (Katz et al., 1970 ; Edjolo et al., 2016).
Each item is graded according to the level of dependence as follows: performs independently (0 point), performs with assistance (1 point), and unable to perform (2 point).
A total score of 0 indicates "full function" and 12 indicates "severe functional impairment".
To evaluate the primary outcome, only the score at the two first items (bathing and dressing, scoring from 0 to 4) will be taken into account for the analysis: complete dependency is present if the score at the two first items is 4 and absent if <4.
|
24 months after inclusion
|
BADL dependency in both bathing and dressing at 30 months
Time Frame: 30 months after inclusion
|
Katz scale ranks the adequacy of performance in six basic functions including bathing, dressing, toileting, transferring,continence, and feeding..
It has been shown that bathing and dressing are the first ADL to be lost, also defined by Katz et al. as the thresholds for disability (Katz et al., 1970 ; Edjolo et al., 2016).
Each item is graded according to the level of dependence as follows: performs independently (0 point), performs with assistance (1 point), and unable to perform (2 point).
A total score of 0 indicates "full function" and 12 indicates "severe functional impairment".
To evaluate the primary outcome, only the score at the two first items (bathing and dressing, scoring from 0 to 4) will be taken into account for the analysis: complete dependency is present if the score at the two first items is 4 and absent if <4.
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30 months after inclusion
|
BADL dependency in both bathing and dressing at 36 months
Time Frame: 36 months after inclusion
|
Katz scale ranks the adequacy of performance in six basic functions including bathing, dressing, toileting, transferring,continence, and feeding..
It has been shown that bathing and dressing are the first ADL to be lost, also defined by Katz et al. as the thresholds for disability (Katz et al., 1970 ; Edjolo et al., 2016).
Each item is graded according to the level of dependence as follows: performs independently (0 point), performs with assistance (1 point), and unable to perform (2 point).
A total score of 0 indicates "full function" and 12 indicates "severe functional impairment".
To evaluate the primary outcome, only the score at the two first items (bathing and dressing, scoring from 0 to 4) will be taken into account for the analysis: complete dependency is present if the score at the two first items is 4 and absent if <4.
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36 months after inclusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavioral and Psychological Symptoms of Dementia (BPSD) as measured by Neuropsychiatric Inventory (NPI) at the inclusion
Time Frame: at the inclusion
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The NPI is a caregiver administered scale which assesses 12 domains of BPSD in dementia (Cummings et al., 1994).
The NPI has been validated in French (Robert et al., 1998) .
It is a questionnaire composed of a screening question and seven to nine items for each of 12 domains : delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep, appetite and eating disorders.
A knowledgeable informant (usually a caregiver) indicates via the screening question whether the patient has experienced any domain-related symptom in the past month.
If the screening question is validated, the caregiver is then asked whether each item within the domain has occurred in the past month and provides a global rating of frequency, severity and caregiver distress for all items in the domain at the same time (not item by item).
Score ranges from 0 to 144 .
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at the inclusion
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BPSD as measured by NPI at 12 months after inclusion
Time Frame: at 12 months after inclusion
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The NPI is a caregiver administered scale which assesses 12 domains of BPSD in dementia (Cummings et al., 1994).
The NPI has been validated in French (Robert et al., 1998) .
It is a questionnaire composed of a screening question and seven to nine items for each of 12 domains : delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep, appetite and eating disorders.
A knowledgeable informant (usually a caregiver) indicates via the screening question whether the patient has experienced any domain-related symptom in the past month.
If the screening question is validated, the caregiver is then asked whether each item within the domain has occurred in the past month and provides a global rating of frequency, severity and caregiver distress for all items in the domain at the same time (not item by item).
Score ranges from 0 to 144 .
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at 12 months after inclusion
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BPSD as measured by NPI at 24 months after inclusion
Time Frame: at 24 months after inclusion
|
The NPI is a caregiver administered scale which assesses 12 domains of BPSD in dementia (Cummings et al., 1994).
The NPI has been validated in French (Robert et al., 1998) .
It is a questionnaire composed of a screening question and seven to nine items for each of 12 domains : delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep, appetite and eating disorders.
A knowledgeable informant (usually a caregiver) indicates via the screening question whether the patient has experienced any domain-related symptom in the past month.
If the screening question is validated, the caregiver is then asked whether each item within the domain has occurred in the past month and provides a global rating of frequency, severity and caregiver distress for all items in the domain at the same time (not item by item).
Score ranges from 0 to 144 .
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at 24 months after inclusion
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BPSD as measured by NPI at 36 months after inclusion
Time Frame: at 36 months after inclusion
|
The NPI is a caregiver administered scale which assesses 12 domains of BPSD in dementia (Cummings et al., 1994).
The NPI has been validated in French (Robert et al., 1998) .
It is a questionnaire composed of a screening question and seven to nine items for each of 12 domains : delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep, appetite and eating disorders.
A knowledgeable informant (usually a caregiver) indicates via the screening question whether the patient has experienced any domain-related symptom in the past month.
If the screening question is validated, the caregiver is then asked whether each item within the domain has occurred in the past month and provides a global rating of frequency, severity and caregiver distress for all items in the domain at the same time (not item by item).
Score ranges from 0 to 144 .
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at 36 months after inclusion
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Depression as measured by the Cornell Scale for Depression in Dementia at inclusion
Time Frame: at inclusion
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the Cornell Scale for Depression in Dementia is a 19-item clinician-administered instrument that uses information from interviews with both the patient and an informant, specifically designed for the rating of symptoms of depression in demented patients (Alexopoulos et al., 1988).
Items were constructed so they can be rated primarily on the basis of observation, and not self report by the patient.
The severity of each item is described as absent, mild or intermittent, and severe.
The informant is interviewed first.
Time of administration is about 30 minutes.
The CSDD has been validated in French (Camus et al., 1995).
Mean scores are given in the original paper, as a function of MMSE for no depression, episodic minor depressive disorder, probable major depressive disorder and definite major depressive disorder.
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at inclusion
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Depression as measured by the Cornell Scale for Depression in Dementia at 12 months after inclusion
Time Frame: at 12 months after inclusion
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the Cornell Scale for Depression in Dementia is a 19-item clinician-administered instrument that uses information from interviews with both the patient and an informant, specifically designed for the rating of symptoms of depression in demented patients (Alexopoulos et al., 1988).
Items were constructed so they can be rated primarily on the basis of observation, and not self report by the patient.
The severity of each item is described as absent, mild or intermittent, and severe.
The informant is interviewed first.
Time of administration is about 30 minutes.
The CSDD has been validated in French (Camus et al., 1995).
Mean scores are given in the original paper, as a function of MMSE for no depression, episodic minor depressive disorder, probable major depressive disorder and definite major depressive disorder.
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at 12 months after inclusion
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Depression as measured by the Cornell Scale for Depression in Dementia at 24 months after inclusion
Time Frame: at 24 months after inclusion
|
the Cornell Scale for Depression in Dementia is a 19-item clinician-administered instrument that uses information from interviews with both the patient and an informant, specifically designed for the rating of symptoms of depression in demented patients (Alexopoulos et al., 1988).
Items were constructed so they can be rated primarily on the basis of observation, and not self report by the patient.
The severity of each item is described as absent, mild or intermittent, and severe.
The informant is interviewed first.
Time of administration is about 30 minutes.
The CSDD has been validated in French (Camus et al., 1995).
Mean scores are given in the original paper, as a function of MMSE for no depression, episodic minor depressive disorder, probable major depressive disorder and definite major depressive disorder.
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at 24 months after inclusion
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Depression as measured by the Cornell Scale for Depression in Dementia at 36 months after inclusion
Time Frame: at 36 months after inclusion
|
the Cornell Scale for Depression in Dementia is a 19-item clinician-administered instrument that uses information from interviews with both the patient and an informant, specifically designed for the rating of symptoms of depression in demented patients (Alexopoulos et al., 1988).
Items were constructed so they can be rated primarily on the basis of observation, and not self report by the patient.
The severity of each item is described as absent, mild or intermittent, and severe.
The informant is interviewed first.
Time of administration is about 30 minutes.
The CSDD has been validated in French (Camus et al., 1995).
Mean scores are given in the original paper, as a function of MMSE for no depression, episodic minor depressive disorder, probable major depressive disorder and definite major depressive disorder.
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at 36 months after inclusion
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Institutionalization
Time Frame: at 36 months after inclusion
|
date of institutionalization
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at 36 months after inclusion
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Death
Time Frame: at 36 months after inclusion
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date of death
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at 36 months after inclusion
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BPSD other than depression at inclusion
Time Frame: at inclusion
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Neuropsychiatric Inventory with an informant if any (de Medeiros et al., 2010).
This scale will be administered by an experienced clinician or psychologist.
Both the subscore of each of the 12 domains and the total score will be analysed
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at inclusion
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BPSD other than depression at 12 months after inclusion
Time Frame: at 12 months after inclusion
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Neuropsychiatric Inventory with an informant if any (de Medeiros et al., 2010).
This scale will be administered by an experienced clinician or psychologist.
Both the subscore of each of the 12 domains and the total score will be analysed
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at 12 months after inclusion
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BPSD other than depression at 24 months after inclusion
Time Frame: at 24 months after inclusion
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Neuropsychiatric Inventory with an informant if any (de Medeiros et al., 2010).
This scale will be administered by an experienced clinician or psychologist.
Both the subscore of each of the 12 domains and the total score will be analysed
|
at 24 months after inclusion
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BPSD other than depression at 36 months after inclusion
Time Frame: at 36 months after inclusion
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Neuropsychiatric Inventory with an informant if any (de Medeiros et al., 2010).
This scale will be administered by an experienced clinician or psychologist.
Both the subscore of each of the 12 domains and the total score will be analysed
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at 36 months after inclusion
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sophie AURIACOMBE, M.D, University Hospital, Bordeaux
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2018/68
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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