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

Recruiting

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

• Registration Number: NCT05597410
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-03-01
• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-24
• Last Update Submitted: 2022-10-24
• Study First Posted: 2022-10-28
• Last Update Posted: 2022-10-28
• Primary Completion: 2029-03
• Study Completion: 2030-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3418

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of cognitive impairment at 5 years	5 years	Number of participants who covert to AD or mild cognitive impairment (MCI) will be recorded to calculate the incidence.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Boston naming test (BNT) at 5 years	5 years	MoCA is a screening instrument used to assess object naming function. The total score ranges from 0 to 30, with lower scores indicating greater disease severity.
Change From Baseline in Mini-Mental State Examination (MMSE) at 5 years	5 years	MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges from 0 to 30; lower score indicates greater disease severity.
Change From Baseline in Montreal cognitive assessment-Basic (MoCA) at 5 years	5 years	MoCA is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges from 0 to 30; lower score indicates greater disease severity.
Change From Baseline in the auditory verbal learning test (AVLT) at 5 years	5 years	AVLT is a screening instrument used to assess the function of memory. The score in long-term memory (N5) ranges from 0 to 12, with lower scores indicating greater disease severity.
Change From multi-modal MRI neuroimaging at 5 years	5 years	Evaluation of multimodal MRI, including high-resolution structural T1 imaging, functional MRI, diffusion tensor imaging and quantitative susceptibility mapping.
Change From Baseline in trail making test (TMT) at 5 years	5 years	AVLT is a screening instrument used to assess the executive function. Time consumed is recorded as the result, with higher scores indicating greater disease severity.
Change From Baseline in Geriatric Depression Scale (GDS) at 5 years	5 years	GDS is a neuropsychological scale used to assess the level of depression. The total score ranges from 0 to 30, with higher scores indicating greater disease severity.

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China