NCT04254094

A Cohort Study of Early Onset Neurodegenerative Dementias Prognostic Factors

Study of Behavioural and Psychological Symptoms as Functional Prognostic Factors in Neurodegenerative Early Onset Major Neurocognitive Disorders

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 163 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: —

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.

Conditions

• Dementia

Interventions

Type	Name	Description
OTHER	Neuropsychological scales	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

Timeline

• Start date: 2020-05-20
• Primary completion: 2026-05-20
• Completion: 2026-05-20
• First posted: 2020-02-05
• Last updated: 2023-10-06

Locations

1 site across 1 country: France