Cohort study for management of patients with early-onset dementia

Not Applicable

• Conditions: Diseases of the nervous system

• Registration Number: KCT0006650
• Lead Sponsor: Pusan National University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 November 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

#Patients
? Early onset AD
? Onset age between 19-64 years
? Meets DSM-V criteria for Dementia (American Psychiatric Association. 2013)
? Meets NIA-AA criteria for Probable AD dementia (McKhann et al., 2011)
? Amyloid positive status (PET scan) or A+T+N+ status based on CSF AD biomarkers
? Must have a caregiver who can provide information about the participant’s cognitive and functional performance
? Willing and able to consent to the protocol
? Early onset MCI
? Onset age between 19-64 years
? Memory or cognitive functions complaint, preferably corroborated by an informant
? Preserved activities of daily living
? Not demented
? Amyloid positive status (PET scan) or A+T+N+ status based on CSF AD biomarkers
? Must have a caregiver who can provide information about the participant’s cognitive and functional performance
? Willing and able to consent to the protocol
? Early SCD
? Onset age between 19-64 years
? Subjective cognitive impairment
? Meets criteria for cognitively normal, based on neuropsychological test
? Amyloid positive status (PET scan) or A+T+N+ status based on CSF AD biomarkers
? Willing and able to consent to the protocol
? FTD
? Onset age between 19-64 years
? Meets criteria for bvFTD (Rascovsky et al., 2011)
? Meets criteria for svPPA (Gorno-Tempini et al., 2011)
? Meets criteria for nfvPPA (Gorno-Tempini et al., 2011)
? Meets El Escorial criteria for MND combined with FTD
? Must have a caregiver who can provide information about the participant’s cognitive and functional performance
? Willing and able to consent to the protocol

? Other EOD
? Onset age between 19-64 years
? Leukodystrophy
? Early onset neurodegenerative dementia other than FTD or EOAD
? Other unspecified EOD
? Must have a caregiver who can provide information about the participant’s cognitive and functional performance
? Willing and able to consent to the protocol
# Family Members
? Family members whose patient has known pathogenic mutations, two or more first degree family members with EOD, or one or more family member with EOD for 3 generations
? Willing and able to consent to the protocol

Exclusion Criteria

? History of major psychiatric disorders (schizophrenia, major depression, bipolar disorders, alcohol/substance abuse, delirium, etc.)
? History of cerebral infarction, cerebral hemorrhage, brain tumor or systemic disease which could affect cognitive functions
? Contraindications to MRI or CT (e.g., claustrophobia, pacemaker, select aneurismal clip, metal fragments, or ventriculoperitoneal shunt, etc.)
? Illiteracy
? Previous enrollment in a therapeutic trial
? Pregnant or lactating
? Deemed ineligible by the site PI for any other reason

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Demographic data, Clinical data (neuropsychological tests, blood test, brain MRI, PET, WES)

Secondary Outcome Measures

Name	Time	Method
no data