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

NCT ID: NCT05597410

Last Updated: 2022-10-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 3418 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2030-03-31

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

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

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gang Wang, MD, PhD

Role: STUDY_CHAIR

Ruijin Hospital

Locations

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Gang Wang, MD, PhD

Role: CONTACT

wg11424@rjh.com.cn

086-021-64370045

Facility Contacts

Ran Tang, MD

Role: primary

hellotangran@163.com

18221457023

References

Cannon-Albright LA, Foster NL, Schliep K, Farnham JM, Teerlink CC, Kaddas H, Tschanz J, Corcoran C, Kauwe JSK. Relative risk for Alzheimer disease based on complete family history. Neurology. 2019 Apr 9;92(15):e1745-e1753. doi: 10.1212/WNL.0000000000007231. Epub 2019 Mar 13.

Reference Type: BACKGROUND

PMID: 30867271 (View on PubMed)

Other Identifiers

SHARAD-01

Identifier Type: -

Identifier Source: org_study_id