NCT06534658

Brief Summary

This project is a multicenter observational study that establishes a longitudinal cohort of patients with Alzheimer's disease and other dementias based on neuroimaging, molecular imaging, biological and digital markers to explore new solutions such as dementia disease mechanism, diagnosis, condition evaluation, and prognosis assessment.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
41mo left

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

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 Progress64%
Jul 2020Aug 2029

Study Start

First participant enrolled

July 30, 2020

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2029

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2029

Last Updated

August 2, 2024

Status Verified

July 1, 2024

Enrollment Period

9 years

First QC Date

July 18, 2024

Last Update Submit

July 30, 2024

Conditions

Keywords

Alzheimer Diseasemolecular imaging

Outcome Measures

Primary Outcomes (1)

  • The change of incidence of cognitive impairment

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

    baseline, 1 year, 2 year, 3 year, 4 year

Secondary Outcomes (13)

  • The change of Mini-Mental State Examination (MMSE)

    baseline, 1 year, 2 year, 3 year, 4 year

  • The change of Montreal cognitive assessment-Basic (MoCA)

    baseline, 1 year, 2 year, 3 year, 4 year

  • The change of Auditory verbal learning test (AVLT)

    baseline, 1 year, 2 year, 3 year, 4 year

  • The change of structural MRI

    baseline, 1 year, 2 year, 3 year, 4 year

  • The change of functional MRI

    baseline, 1 year, 2 year, 3 year, 4 year

  • +8 more secondary outcomes

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The population in this study includes the cognitive impairment patients in Ruijin Hospital, Renji Hospital, The First Hospital of Zhejiang University School of Medicine, The First Hospital of China Medical University.

You may qualify if:

  • Patients aged ≥50 and ≤85 years old, male or female;
  • Meet the diagnostic criteria for dementia or MCI;
  • Neuropsychological score: MMSE 15-28 points, CDR ≤ 1 point; ④ Patients and their families are informed and sign the informed consent form

You may not qualify if:

  • The presence of other neurological diseases that may cause brain dysfunction (such as depression, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal intracranial pressure hydrocephalus, etc.);
  • The presence of other systemic diseases that may cause cognitive impairment (such as liver dysfunction, renal dysfunction, thyroid dysfunction, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.);
  • Suffering from a disease that makes it impossible to cooperate with cognitive examinations;
  • The presence of contraindications to MRI;
  • The presence of mental and neurological retardation;
  • Refusing to draw blood;
  • Refusing to sign the informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, China

RECRUITING

First Affiliated Hospital of Zhejiang University School of Medicine

Hanzhong, Hangzhou, China

RECRUITING

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Cangzhou, Hebei, China

RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

Qilu Hospital of Shandong University, Qingdao Branch

Qingdao, Shandong, China

RECRUITING

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

The First Affiliated Hospital of China Medical University

Shenyang, Shenyang, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Gang Wang, PhD. MD.

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2024

First Posted

August 2, 2024

Study Start

July 30, 2020

Primary Completion (Estimated)

July 30, 2029

Study Completion (Estimated)

August 30, 2029

Last Updated

August 2, 2024

Record last verified: 2024-07

Locations