Shanghai At Risk for Alzheimer's Disease: a Cohort Study (SHARAD)

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Alzheimer Disease; Cognitive Impairment; Neurodegenerative Diseases; Neurocognitive Disorders; Dementia

Study type: Observational

Funder types: Other

Identifiers

NCT05597410

SHARAD-01

Details and patient eligibility

About

The goal of this cohort study is to estimate the incidence of AD in the first-degree relatives of patients with AD. The main questions it aims to answer are:

• cognitive changes of subjects at high risk of AD as ageing;
• environmental and behavioral factors affecting AD incidence.

Full description

This study is a prospective cohort study focusing on the first-degree relatives of patients with Alzheimer's disease (AD). Multiple methods including the neuropsychiatric assessment battery, magnetic resonance imaging (MRI) and fluid biomarkers (blood and urine) are used to estimate the longitudinal changes of the participants at high risk of AD. Besides, a structured questionnaire is designed to investigate how environmental, behavioral and other factors influence the incidence of AD. This study is of great significance in establishing novel guidelines for the prevention and treatment of dementia suitable for Chinese population, and for clinicians to predict the risk of AD in first-degree relatives.

Enrollment: 3,418 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. the AD diagnostic criteria of probands meet the 2011 National Institute on Aging - Alzheimer's Association framework, and participants are the first-degree relatives (including parents, children and siblings of the same father and mother) of the proband;
2. not patients with dementia;
3. ≥ 50 years, males and females;
4. subjects have lived in Shanghai for more than 1 year and have no plan to move out of Shanghai within 5 years;
5. subjects are able to complete investigation, physical examination, imaging examination and biological specimen collection.

Exclusion criteria

Individuals will be excluded if they have:

1. other diseases which could cause cognitive decline, e.g. cerebrovascular diseases, Creutzfeldt-Jakob disease and Parkinsons disease;
2. history of psychological disorders (according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition);
3. uncorrectable visual or auditory impairment that hampers the completion of related examination.
4. pre-menopausal women will also be excluded.