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

Alzheimer Disease Clinical Trial

— SHARAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05597410
• Other study ID #: SHARAD-01
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: March 2030

Study information

• Verified date: March 2022
• Source: Ruijin Hospital
• Contact: Gang Wang, MD, PhD
• Phone: 086-021-64370045
• Email: wg11424[@]rjh.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3418
• Est. completion date: March 2030
• Est. primary completion date: March 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in Blood concentration of Phosphorylated Tau (p-tau) at 5 years	Blood p-tau 181 and p-tau 217 at baseline will be tested. The higher blood p-tau is a strong predictor for AD.	5 years
Other	Change From Baseline in Blood Concentration of Amyloid ß (Aß) at 5 years	Blood Aß40 and Aß42 at baseline will be tested. The decreased blood Aß42/40 ratio is a strong predictor for AD.	5 years
Primary	Incidence of cognitive impairment at 5 years	Number of participants who covert to AD or mild cognitive impairment (MCI) will be recorded to calculate the incidence.	5 years
Secondary	Change From Baseline in Mini-Mental State Examination (MMSE) at 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.	5 years
Secondary	Change From Baseline in Montreal cognitive assessment-Basic (MoCA) at 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.	5 years
Secondary	Change From Baseline in Boston naming test (BNT) at 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.	5 years
Secondary	Change From Baseline in the auditory verbal learning test (AVLT) at 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.	5 years
Secondary	Change From Baseline in trail making test (TMT) at 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.	5 years
Secondary	Change From Baseline in Geriatric Depression Scale (GDS) at 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.	5 years
Secondary	Change From multi-modal MRI neuroimaging at 5 years	Evaluation of multimodal MRI, including high-resolution structural T1 imaging, functional MRI, diffusion tensor imaging and quantitative susceptibility mapping.	5 years