China Alzheimer's and Neurodegenerative Disorder Research

NCT04320368 | Unknown DMC

• 1 other identifier: Z181100001518005
• Study Type: observational
• Target: 3,100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center study that has three cohorts: 1) cognitive normal cohort (CN), 2) Alzheimer's disease cohort (AD) and 3) vascular cognitive impairment cohort (VCI). The goal of this study is to understand the risk factors of AD and VCI and to identify high risk patients for early intervention. It will collect demographic information, family history, medical history, neuropsychological tests, imaging studies and biological samples through standard and uniform procedures.

Conditions

Cognitive Impairment

Keywords

Alzheimer's disease; vascular cognitive impairment; dementia

Outcome Measures

Primary Outcomes (2)

• Data records

  We will record the number of participants at several follow-up visits, the basic condition at the follow-up. If the visit is not completed, record the cause of this loss. At baseline, record the demographic information, past medical history and medication history, vital signs and neuropsychological scales. The PET-CT scan were recorded during the 4-year visit. Collect the results of cerebral MRI, laboratory tests and neuropsychological scales of all participants at baseline, 12, 24, 36 and 48 months and biological samples. For VCI cohort, we will record the basic conditions and partial neuropsychological scales at 3-month and 6-month follow-up.

  4-5 years

• Neuropsychological scales

  Mini-Mental State Examination (MMSE), Montreal-Cognitive Assessment (MoCA), the Geriatric Depression Scale (GDS), The Activities of Daily Living Questionnaire(ADL), Digit Span Memory Test, Rey Auditory Verbal Learning Test (RAVLT), Rey-Osterrieth Complex Figure Test(ROCF), Trail Making Test A and B, Stroop test, Verbal Fluency Test, Boston Naming Test, Clock-Drawing Test, Narcissism Test (NPI), Symbol Digit Modalities Test(SDMT), Clinical Dementia Rating (CDR)

  4-5 years

Study Arms (3)

Alzheimer's disease cohort

1. Aged 40-100 years old (≥ 40 years old, ≤ 100 years old). 2. Diagnosed with AD according to Alzheimer disease diagnostic criteria following NINCDS-ADRDA 1984 or NIA-AA 2011 guideline. 3. Had adequate hearing, vision and comprehension and verbal expression to complete the cognitive assessments. 4. Had at least 3 years of education. 5. Signed informed consent.

Post-stroke cognitive observation cohort

1. Aged 40-100-years old (≥ 40 years old, ≤ 100 years old). 2. Cerebral infarction is diagnosed according to World Health Organization diagnostic criteria and was the first symptomatic onset. 3. The time from onset to enrollment was less than 7 days. 4. Had adequate hearing, vision and comprehension and verbal expression to complete the cognitive assessments. 5. Had at least 3 years of education. 6. Signed informed consent.

A cohort of people with normal cognitive function

1. Aged 40-100 years old (≥ 40 years old, ≤ 100 years old). 2. The patients are cognitively normal and able to live and work independently 3. Had adequate hearing, vision and comprehension and verbal expression to complete the cognitive assessments. 4. Had at least 3 years of education. 5. Signed informed consent.

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Alzheimer's disease cohort and post-stroke cognitive observation cohort will be recruited from participating hospitals. Cognitively normal cohort will be recruited from the community.

You may not qualify if:

• Had adequate hearing, vision and comprehension and verbal expression to complete the cognitive assessments.
• Had at least 3 years of education. 1.1.5 Signed informed consent.
• Previous history of instable epilepsy. 1.2.3 Systemic diseases affect the central nervous system (CNS), such as abnormal liver and kidney functions.
• History of hereditary diseases that affect cognitive function (such as Huntington's disease, Down's syndrome, CADASIL, adrenal leukodystrophy, mitochondrial encephalopathy, etc.).
• Infection and immune-related diseases affecting the central nervous system (systemic lupus erythematosus, undertreated HIV infection or a history of CNS syphilis infection, etc.).
• Metabolic and endocrine disorders (requiring new treatment or adjustment of current treatment for thyroid dysfunction, folate or vitamin B12 deficiency).
• Had contraindications for MRI (e.g., pacemakers, stents, claustrophobia.) or did not cooperate with PET scans.
• The time from onset to enrollment was less than 7 days. 2.1.4 Had adequate hearing, vision and comprehension and verbal expression to complete the cognitive assessments.
• Had at least 3 years of education. 2.1.6 Signed informed consent.
• Sequelae after previous history of severe central nervous system infection, multiple sclerosis, autoimmune encephalitis, Hashimoto's encephalopathy, etc.
• Previous history of instable epilepsy. 2.2.4 Systemic diseases affect the CNS, for abnormal liver and kidney functions.
• History of hereditary diseases that affect cognitive function (such as Huntington's disease, down syndrome, CADASIL, adrenal leukodystrophy, mitochondrial encephalopathy, etc.).
• Infection and immune-related diseases affecting the central nervous system (systemic lupus erythematosus, undertreated HIV infection or a history of CNS syphilis infection, etc.).
• Metabolic and endocrine disorders (requiring new treatment or adjustment of current treatment for thyroid dysfunction, folate or vitamin B12 deficiency).
• Reject or had contraindications for MRI (e.g., pacemakers, stents, claustrophobia.).

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital，Capital Medical University

Beijing, Beijing Municipality, 110000, China

RECRUITING

Related Publications (5)

• Prince MJ, Wu F, Guo Y, Gutierrez Robledo LM, O'Donnell M, Sullivan R, Yusuf S. The burden of disease in older people and implications for health policy and practice. Lancet. 2015 Feb 7;385(9967):549-62. doi: 10.1016/S0140-6736(14)61347-7. Epub 2014 Nov 6.

  PMID: 25468153 BACKGROUND

• Alzheimer's Association. 2016 Alzheimer's disease facts and figures. Alzheimers Dement. 2016 Apr;12(4):459-509. doi: 10.1016/j.jalz.2016.03.001.

  PMID: 27570871 BACKGROUND

• Wang Y, Wang Q, Tong L, Zheng H, Wang Y, Li S. U-shaped association between post-stroke cognitive impairment and high-density lipoprotein cholesterol at the acute period of stroke. Arch Gerontol Geriatr. 2025 Dec;139:106002. doi: 10.1016/j.archger.2025.106002. Epub 2025 Aug 26.

  PMID: 40915091 DERIVED

• Wang Q, Wang Y, Li S, Shi J. PACAP-Sirtuin3 alleviates cognitive impairment through autophagy in Alzheimer's disease. Alzheimers Res Ther. 2023 Oct 27;15(1):184. doi: 10.1186/s13195-023-01334-2.

  PMID: 37891608 DERIVED

• Wang Y, Wang S, Zhu W, Liang N, Zhang C, Pei Y, Wang Q, Li S, Shi J. Reading activities compensate for low education-related cognitive deficits. Alzheimers Res Ther. 2022 Oct 14;14(1):156. doi: 10.1186/s13195-022-01098-1.

  PMID: 36242017 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood, saliva, urine and feces

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Shiping Li, MD

  Beijing Tiantan Hospital

  STUDY CHAIR

Central Study Contacts

Shiping Li, Doctor

CONTACT

+86 15830116199; drlishiping@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 25, 2020
• Study Start: July 8, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available at one year after the study completion.
• Access Criteria: Committee review

Locations

CN (1)