Alzheimer DiseaseSHARADNCT05597410
Shanghai At Risk for Alzheimer's Disease: a Cohort Study
An observational study of Alzheimer Disease and Dementia, run by Ruijin Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia, Neurodegenerative Diseases
- How many people
- 3,418 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Ran Tang, MD, 18221457023, hellotangran@163.com
Wang Gang, MD, PhD
About this 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.
Read the 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.
- Conditions
- Alzheimer Disease, Dementia, Neurodegenerative Diseases, Cognitive Impairment, Neurocognitive Disorders
- Medical subject headings
- Alzheimer Disease, Dementia, Neurodegenerative Diseases, Cognitive Dysfunction, Neurocognitive Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (7)
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.
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start1 Mar 2022
- Primary completionMar 2029 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,418 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gang Wang, MD, PhD, Study chair, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597410
- Sponsor's protocol ID
- SHARAD-01
- Acronym
- SHARAD
- Status last verified
- Mar 2022
- First submitted
- 12 Oct 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 30867271
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai At Risk for Alzheimer's Disease: a Cohort Study
- ClinicalTrials.gov ID
- NCT05597410
- Acronym / sponsor ID
- SHARAD / SHARAD-01
- Conditions
- Alzheimer Disease, Dementia, Neurodegenerative Diseases, Cognitive Impairment, Neurocognitive Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,418 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Background: PubMed 30867271Cannon-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gang Wang, MD, PhD study chair
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Dementia, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gang Wang, MD, PhD (086-021-64370045, wg11424@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cognitive impairment at 5 years (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05597410, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.