A Cohort Study of Early Onset Neurodegenerative Dementias Prognostic Factors

NCT ID: NCT04254094

Last Updated: 2023-10-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 163 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-20
• Study Completion Date: 2026-05-20

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.

Conditions

Dementia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Early onset dementias (EOD)

Prospective multicenter cohort of EOD patients with a three-year follow-up in tertiary Reference Memory centers

Neuropsychological scales

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sophie AURIACOMBE, M.D

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

CHU de Bordeaux

Bordeaux, , France

Countries

France

Other Identifiers

CHUBX 2018/68

Identifier Type: -

Identifier Source: org_study_id