Clinical trial NCT04254094: A Cohort Study of Early Onset Neurodegenerative Dementias Prognostic Factors
Official title: Study of Behavioural and Psychological Symptoms as Functional Prognostic Factors in Neurodegenerative Early Onset Major Neurocognitive Disorders
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dementia
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed neurodegenerative (within 6 months) EOD according to international consensus criteria with symptoms onset before 65 years old

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Newly diagnosed neurodegenerative (within 6 months) EOD according to international consensus criteria
2. Symptoms onset before 65 years old
3. Clinical Dementia Rating Scale (CDR) 0.5 to 1 both inclusive
4. Affiliated person or beneficiary of a social security scheme.
5. 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
6. Able to participate to cognitive and psychiatric assessments

Exclusion Criteria:

1. Non degenerative dementias : e;g. vascular, alcohol-related, toxic, infectious, posttraumatic.
2. Dementia of unknown etiology
3. Dementia in Down syndrome
4. Patients in Nursing Home or other care facility
5. Total dependency for dressing and/or bathing at the time of inclusion
6. Patient with a severe or life-threatening disease

   -

Primary outcomes:
measure: BADL dependency in both bathing and dressing using the BADL scale from Katz (Katz et al., 1970) at inclusion
timeFrame: at inclusion
measure: BADL dependency in both bathing and dressing using the BADL scale from Katz (Katz et al., 1970) at 6 months
timeFrame: 6 months after inclusion
measure: BADL dependency in both bathing and dressing at 12 months
timeFrame: 12 months after inclusion
measure: BADL dependency in both bathing and dressing at 18 months
timeFrame: 18 months after inclusion
measure: BADL dependency in both bathing and dressing at 24 months
timeFrame: 24 months after inclusion
measure: BADL dependency in both bathing and dressing at 30 months
timeFrame: 30 months after inclusion
measure: BADL dependency in both bathing and dressing at 36 months
timeFrame: 36 months after inclusion
Secondary outcomes:
measure: Behavioral and Psychological Symptoms of Dementia (BPSD) as measured by Neuropsychiatric Inventory (NPI) at the inclusion
timeFrame: at the inclusion
measure: BPSD as measured by NPI at 12 months after inclusion
timeFrame: at 12 months after inclusion
measure: BPSD as measured by NPI at 24 months after inclusion
timeFrame: at 24 months after inclusion
measure: BPSD as measured by NPI at 36 months after inclusion
timeFrame: at 36 months after inclusion
measure: Depression as measured by the Cornell Scale for Depression in Dementia at inclusion
timeFrame: at inclusion
measure: Depression as measured by the Cornell Scale for Depression in Dementia at 12 months after inclusion
timeFrame: at 12 months after inclusion
measure: Depression as measured by the Cornell Scale for Depression in Dementia at 24 months after inclusion
timeFrame: at 24 months after inclusion
measure: Depression as measured by the Cornell Scale for Depression in Dementia at 36 months after inclusion
timeFrame: at 36 months after inclusion
measure: Institutionalization
timeFrame: at 36 months after inclusion
measure: Death
timeFrame: at 36 months after inclusion
measure: BPSD other than depression at inclusion
timeFrame: at inclusion
measure: BPSD other than depression at 12 months after inclusion
timeFrame: at 12 months after inclusion
measure: BPSD other than depression at 24 months after inclusion
timeFrame: at 24 months after inclusion
measure: BPSD other than depression at 36 months after inclusion
timeFrame: at 36 months after inclusion
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Sophie AURIACOMBE, M.D
role: PRINCIPAL_INVESTIGATOR
References: