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NCT Number: NCT05597410

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

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

Ran Tang, MD

CONTACT

[email protected]

18221457023

Wang Gang, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of cognitive impairment at 5 years

    Time frame: 5 years

    Number of participants who covert to AD or mild cognitive impairment (MCI) will be recorded to calculate the incidence.

Secondary outcomes

  1. Change From Baseline in Mini-Mental State Examination (MMSE) at 5 years

    Time frame: 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.

  2. Change From Baseline in Montreal cognitive assessment-Basic (MoCA) at 5 years

    Time frame: 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.

  3. Change From Baseline in Boston naming test (BNT) at 5 years

    Time frame: 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.

  4. Change From Baseline in the auditory verbal learning test (AVLT) at 5 years

    Time frame: 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. Change From Baseline in trail making test (TMT) at 5 years

    Time frame: 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.

  6. Change From Baseline in Geriatric Depression Scale (GDS) at 5 years

    Time frame: 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.

  7. Change From multi-modal MRI neuroimaging at 5 years

    Time frame: 5 years

    Evaluation of multimodal MRI, including high-resolution structural T1 imaging, functional MRI, diffusion tensor imaging and quantitative susceptibility mapping.

Other outcomes

  1. Change From Baseline in Blood concentration of Phosphorylated Tau (p-tau) at 5 years

    Time frame: 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.

  2. Change From Baseline in Blood Concentration of Amyloid β (Aβ) at 5 years

    Time frame: 5 years

    Blood Aβ40 and Aβ42 at baseline will be tested. The decreased blood Aβ42/40 ratio is a strong predictor for AD.

Study contacts

Contact information is provided by the study sponsor or research team.

Gang Wang, MD, PhD

CONTACT

[email protected]

086-021-64370045

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Acronym: SHARAD

Important dates

Study start
2022
Primary completion
2029
Study completion
2030
First posted
Oct 28, 2022
Registry last updated
Oct 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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