NCT05597410

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,418

participants targeted

Target at P75+ for all trials

Timeline
46mo left

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Mar 2022Mar 2030

Study Start

First participant enrolled

March 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2030

Last Updated

October 28, 2022

Status Verified

March 1, 2022

Enrollment Period

7 years

First QC Date

October 12, 2022

Last Update Submit

October 24, 2022

Conditions

Alzheimer DiseaseDementiaNeurodegenerative DiseasesCognitive ImpairmentNeurocognitive Disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

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

    5 years

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

    5 years

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

    5 years

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

    5 years

  • Change From Baseline in trail making test (TMT) at 5 years

    5 years

  • +2 more secondary outcomes

Other Outcomes (2)

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

    5 years

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

    5 years

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related 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.

    PMID: 30867271BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood (3-4 ml) of all participants will be collected at baseline and stored at -80°C.

MeSH Terms

Conditions

Alzheimer DiseaseDementiaNeurodegenerative DiseasesCognitive DysfunctionNeurocognitive Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesMental DisordersCognition Disorders

Study Officials

  • Gang Wang, MD, PhD

    Ruijin Hospital

    STUDY CHAIR

Central Study Contacts

Gang Wang, MD, PhD

CONTACT

086-021-64370045wg11424@rjh.com.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2022

First Posted

October 28, 2022

Study Start

March 1, 2022

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2030

Last Updated

October 28, 2022

Record last verified: 2022-03

Locations

CN(1)