A Cohort Study of Early Onset Neurodegenerative Dementias Prognostic Factors

NCT04254094 | Active Not Recruiting DMC

• 1 other identifier: CHUBX 2018/68
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  36 months after inclusion

Secondary Outcomes (14)

• Behavioral and Psychological Symptoms of Dementia (BPSD) as measured by Neuropsychiatric Inventory (NPI) at the inclusion

  at the inclusion

• BPSD as measured by NPI at 12 months after inclusion

  at 12 months after inclusion

• BPSD as measured by NPI at 24 months after inclusion

  at 24 months after inclusion

• BPSD as measured by NPI at 36 months after inclusion

  at 36 months after inclusion

• Depression as measured by the Cornell Scale for Depression in Dementia at inclusion

  at inclusion

Study Arms (1)

Early onset dementias (EOD)

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

Other: Neuropsychological scales

Interventions

Neuropsychological scales 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

Early onset dementias (EOD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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
• Patient with a severe or life-threatening disease

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sophie AURIACOMBE, M.D

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: May 20, 2020
• Primary Completion: May 20, 2026
• Study Completion: May 20, 2026
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)