Clinical trial NCT05597410: Shanghai At Risk for Alzheimer's Disease: a Cohort Study
Official title: Shanghai At Risk for Alzheimer's Disease: a Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Dementia
Neurodegenerative Diseases
Cognitive Impairment
Neurocognitive Disorders
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 3418
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is the first-degree, cognition-preserved relatives (including parents, children and siblings of the same father and mother) of patients with AD

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.

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.

Primary outcomes:
measure: Incidence of cognitive impairment at 5 years
timeFrame: 5 years
Secondary outcomes:
measure: Change From Baseline in Mini-Mental State Examination (MMSE) at 5 years
timeFrame: 5 years
measure: Change From Baseline in Montreal cognitive assessment-Basic (MoCA) at 5 years
timeFrame: 5 years
measure: Change From Baseline in Boston naming test (BNT) at 5 years
timeFrame: 5 years
measure: Change From Baseline in the auditory verbal learning test (AVLT) at 5 years
timeFrame: 5 years
measure: Change From Baseline in trail making test (TMT) at 5 years
timeFrame: 5 years
measure: Change From Baseline in Geriatric Depression Scale (GDS) at 5 years
timeFrame: 5 years
measure: Change From multi-modal MRI neuroimaging at 5 years
timeFrame: 5 years
Other outcomes:
measure: Change From Baseline in Blood concentration of Phosphorylated Tau (p-tau) at 5 years
timeFrame: 5 years
measure: Change From Baseline in Blood Concentration of Amyloid β (Aβ) at 5 years
timeFrame: 5 years
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Gang Wang, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.