Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT04254094
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-06
First Post:
2020-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Cohort Study of Early Onset Neurodegenerative Dementias Prognostic Factors
Sponsor:
University Hospital, Bordeaux
Organization:
Study Overview
Official Title:
Study of Behavioural and Psychological Symptoms as Functional Prognostic Factors in Neurodegenerative Early Onset Major Neurocognitive Disorders
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEODEM
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: