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Recruiting NCT05597410

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

— Observational Alzheimer Disease Dementia Neurodegenerative Diseases Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Alzheimer Disease, Dementia, Neurodegenerative Diseases, Cognitive Impairment. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Incidence of cognitive impairment at 5 years [Time frame: 5 years]
Secondary outcome measures (7)
  • Change From Baseline in Mini-Mental State Examination (MMSE) at 5 years [Time frame: 5 years]
  • Change From Baseline in Montreal cognitive assessment-Basic (MoCA) at 5 years [Time frame: 5 years]
  • Change From Baseline in Boston naming test (BNT) at 5 years [Time frame: 5 years]
  • Change From Baseline in the auditory verbal learning test (AVLT) at 5 years [Time frame: 5 years]
  • Change From Baseline in trail making test (TMT) at 5 years [Time frame: 5 years]
  • Change From Baseline in Geriatric Depression Scale (GDS) at 5 years [Time frame: 5 years]
  • Change From multi-modal MRI neuroimaging at 5 years [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • 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;
  • not patients with dementia;
  • ≥ 50 years, males and females;
  • subjects have lived in Shanghai for more than 1 year and have no plan to move out of Shanghai within 5 years;
  • subjects are able to complete investigation, physical examination, imaging examination and biological specimen collection.

Exclusion criteria

Individuals will be excluded if they have:

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai

Publications

  • 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. PMID 30867271

Identifiers

NCT: NCT05597410 · SHARAD-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗