DementiaNEODEMNCT04254094
A Cohort Study of Early Onset Neurodegenerative Dementias Prognostic Factors
An observational study of Dementia, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
NEODEM is a multicenter cohort study of patients with early-onset degenerative dementia (before age 65), the main objective of which is to study behavioral disorders and in particular depression as functional prognostic factors at 3 years. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dementia
- What is being tested?
- Neuropsychological scales
- How many people
- 163 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2020to 20 May 2026
- How long will I take part?
- 36 Months
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Newly diagnosed neurodegenerative (within 6 months) EOD according to international consensus criteria with symptoms onset before 65 years old
Who may be able to join
- 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
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Behavioural and Psychological Symptoms as Functional Prognostic Factors in Neurodegenerative Early Onset Major Neurocognitive Disorders
NEODEM is a multicenter cohort study of patients with early-onset degenerative dementia (before age 65), the main objective of which is to study behavioral disorders and in particular depression as functional prognostic factors at 3 years.
Read the 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.
- Conditions
- Dementia
- Being tested
- Neuropsychological scales
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological scalesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Early onset dementias (EOD) | Prospective multicenter cohort of EOD patients with a three-year follow-up in tertiary Reference Memory centers Receives: Other: Neuropsychological scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
BADL dependency in both bathing and dressing using the BADL scale from Katz (Katz et al., 1970) at 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.
Measured: at inclusion
BADL dependency in both bathing and dressing using the BADL scale from Katz (Katz et al., 1970) at 6 months
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.
Measured: 6 months after inclusion
BADL dependency in both bathing and dressing at 12 months
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.
Measured: 12 months after inclusion
BADL dependency in both bathing and dressing at 18 months
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.
Measured: 18 months after inclusion
BADL dependency in both bathing and dressing at 24 months
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.
Measured: 24 months after inclusion
BADL dependency in both bathing and dressing at 30 months
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.
Measured: 30 months after inclusion
BADL dependency in both bathing and dressing at 36 months
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.
Measured: 36 months after inclusion
Secondary outcomes (14)
Behavioral and Psychological Symptoms of Dementia (BPSD) as measured by Neuropsychiatric Inventory (NPI) at the 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 .
Measured: at the inclusion
BPSD as measured by NPI at 12 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 .
Measured: at 12 months after inclusion
BPSD as measured by NPI 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 .
Measured: at 24 months after inclusion
BPSD as measured by NPI 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 .
Measured: at 36 months after inclusion
Depression as measured by the Cornell Scale for Depression in Dementia at 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.
Measured: at inclusion
Depression as measured by the Cornell Scale for Depression in Dementia at 12 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.
Measured: at 12 months after inclusion
Depression as measured by the Cornell Scale for Depression in Dementia 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.
Measured: at 24 months after inclusion
Depression as measured by the Cornell Scale for Depression in Dementia 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.
Measured: at 36 months after inclusion
Institutionalization
date of institutionalization
Measured: at 36 months after inclusion
Death
date of death
Measured: at 36 months after inclusion
BPSD other than depression at inclusion
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
Measured: at inclusion
BPSD other than depression at 12 months after inclusion
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
Measured: at 12 months after inclusion
BPSD other than depression at 24 months after inclusion
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
Measured: at 24 months after inclusion
BPSD other than depression at 36 months after inclusion
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
Measured: at 36 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start20 May 2020
- Primary completion20 May 2026 (estimated)
- Study completion20 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 163 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie AURIACOMBE, M.D, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254094
- Sponsor's protocol ID
- CHUBX 2018/68
- Acronym
- NEODEM
- Status last verified
- Oct 2023
- First submitted
- 31 Jan 2020
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Behavioural and Psychological Symptoms as Functional Prognostic Factors in Neurodegenerative Early Onset Major Neurocognitive Disorders
- ClinicalTrials.gov ID
- NCT04254094
- Acronym / sponsor ID
- NEODEM / CHUBX 2018/68
- Conditions
- Dementia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 163 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 5 Feb 2020 (actual)
- 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.
NEODEM is a multicenter cohort study of patients with early-onset degenerative dementia (before age 65), the main objective of which is to study behavioral disorders and in particular depression as functional prognostic factors at 3 years.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early onset dementias (EOD) | – | Other: Neuropsychological scalesProspective multicenter cohort of EOD patients with a three-year follow-up in tertiary Reference Memory centers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed neurodegenerative (within 6 months) EOD according to international consensus criteria with symptoms onset before 65 years old
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Neuropsychological scalesBasic 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 | Other | Early onset dementias (EOD) |
Primary outcome
BADL dependency in both bathing and dressing using the BADL scale from Katz (Katz et al., 1970) at inclusion
Time frame: at 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.
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.
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.
BADL dependency in both bathing and dressing at 18 months
Time frame: 18 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.
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.
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.
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.
14 secondary outcomes
Behavioral and Psychological Symptoms of Dementia (BPSD) as measured by Neuropsychiatric Inventory (NPI) at the inclusion
Time frame: at the inclusion
BPSD as measured by NPI at 12 months after inclusion
Time frame: at 12 months after inclusion
BPSD as measured by NPI at 24 months after inclusion
Time frame: at 24 months after inclusion
BPSD as measured by NPI at 36 months after inclusion
Time frame: at 36 months after inclusion
Depression as measured by the Cornell Scale for Depression in Dementia at inclusion
Time frame: at inclusion
Depression as measured by the Cornell Scale for Depression in Dementia at 12 months after inclusion
Time frame: at 12 months after inclusion
Depression as measured by the Cornell Scale for Depression in Dementia at 24 months after inclusion
Time frame: at 24 months after inclusion
Depression as measured by the Cornell Scale for Depression in Dementia at 36 months after inclusion
Time frame: at 36 months after inclusion
Institutionalization
Time frame: at 36 months after inclusion
Death
Time frame: at 36 months after inclusion
BPSD other than depression at inclusion
Time frame: at inclusion
BPSD other than depression at 12 months after inclusion
Time frame: at 12 months after inclusion
BPSD other than depression at 24 months after inclusion
Time frame: at 24 months after inclusion
BPSD other than depression at 36 months after inclusion
Time frame: at 36 months after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Sophie AURIACOMBE, M.D principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by University Hospital, Bordeaux 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 7 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 6 Oct 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BADL dependency in both bathing and dressing using the BADL scale from Katz (Katz et al., 1970) at inclusion (time frame: at inclusion). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2023.