Research on Alzheimer's and cognitive impairment in China

China National Clinical Research Center Alzheimer's Disease and Neurodegenerative Disorder Research

This study is looking to find out what factors might increase the risk of Alzheimer's and other types of cognitive impairment in people in China to help identify those who might need early treatment.

Quick facts

• Study type: Observational
• Enrollment: 3100 (estimated)
• Ages: 40 Years to 100 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT04320368 on ClinicalTrials.gov

What this trial studies

This observational study involves three cohorts: cognitive normal individuals, Alzheimer's disease patients, and those with vascular cognitive impairment. It aims to identify risk factors associated with Alzheimer's and vascular cognitive impairment, facilitating early intervention for high-risk patients. Participants will undergo a range of assessments, including demographic data collection, neuropsychological tests, imaging studies, and biological sample analysis over a follow-up period of up to two years. The study employs a case-control design to establish norms within the Chinese population.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 40-100 diagnosed with Alzheimer's disease or those with cognitive impairment.

Not a fit: Patients with severe central nervous system infections or systemic diseases affecting the CNS may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier identification and intervention for individuals at high risk of Alzheimer's and vascular cognitive impairment.

How similar studies have performed: Other studies have shown success in identifying risk factors for cognitive impairment, making this approach promising yet tailored to the Chinese population.

Eligibility criteria

1. The inclusion and exclusion criteria of AD group.

   1.1 The AD group inclusion criteria: 1.1.1 Aged 40-100 years old (≥ 40 years old, ≤ 100 years old). 1.1.2 Diagnosed with AD according to Alzheimer disease diagnostic criteria following NINCDS-ADRDA1984 or NIA-AA 2011 guideline.

   1.1.3 Had adequate hearing, vision and comprehension and verbal expression to complete the cognitive assessments.

   1.1.4 Had at least 3 years of education. 1.1.5 Signed informed consent.

   1.2 The AD group exclusion criteria: 1.2.1 Sequelae after previous history of severe central nervous system infection, multiple sclerosis, autoimmune encephalitis, Hashimoto's encephalopathy, etc.

   1.2.2 Previous history of instable epilepsy. 1.2.3 Systemic diseases affect the central nervous system (CNS), such as abnormal liver and kidney functions.

   1.2.4 History of hereditary diseases that affect cognitive function (such as Huntington's disease, Down's syndrome, CADASIL, adrenal leukodystrophy, mitochondrial encephalopathy, etc.).

   1.2.5 Infection and immune-related diseases affecting the central nervous system (systemic lupus erythematosus, undertreated HIV infection or a history of CNS syphilis infection, etc.).

   1.2.6 Metabolic and endocrine disorders (requiring new treatment or adjustment of current treatment for thyroid dysfunction, folate or vitamin B12 deficiency).

   1.2.7 Had contraindications for MRI (e.g., pacemakers, stents, claustrophobia.) or did not cooperate with PET scans.
2. The inclusion and exclusion criteria of post-stroke cognitive observation group.

   2.1 The inclusion criteria of post-stroke cognitive observation group: 2.1.1 Aged 40-100-years old (≥ 40 years old, ≤ 100 years old). 2.1.2 Cerebral infarction is diagnosed according to World Health Organization diagnostic criteria13 and was the first symptomatic onset.

   2.1.3 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.

   2.1.5 Had at least 3 years of education. 2.1.6 Signed informed consent.

   2.2 The exclusion criteria of post-stroke cognitive observation group: 2.2.1 Prior to the onset of acute infarction had no conditions known to affect cognitive function, such as vascular dementia, dementia with Lewy body dementia, frontotemporal dementia, Parkinson's disease dementia, epilepsy, stroke, hydrocephalus, multiple sclerosis, traumatic brain injuries, genetic disorders affecting cognition, alcoholism, uncontrolled depression or other psychiatric disorders and Alzheimer's disease and IQCODE\>3.5.

   2.2.2 Sequelae after previous history of severe central nervous system infection, multiple sclerosis, autoimmune encephalitis, Hashimoto's encephalopathy, etc.

   2.2.3 Previous history of instable epilepsy. 2.2.4 Systemic diseases affect the CNS, for abnormal liver and kidney functions.

   2.2.5 History of hereditary diseases that affect cognitive function (such as Huntington's disease, down syndrome, CADASIL, adrenal leukodystrophy, mitochondrial encephalopathy, etc.).

   2.2.6 Infection and immune-related diseases affecting the central nervous system (systemic lupus erythematosus, undertreated HIV infection or a history of CNS syphilis infection, etc.).

   2.2.7 Metabolic and endocrine disorders (requiring new treatment or adjustment of current treatment for thyroid dysfunction, folate or vitamin B12 deficiency).

   2.2.8 Reject or had contraindications for MRI (e.g., pacemakers, stents, claustrophobia.).
3. The inclusion and exclusion criteria of normal cognitive group.

3.1 The inclusion criteria of normal cognitive group: 3.1.1 Aged 40-100 years old (≥ 40 years old, ≤ 100 years old). 3.1.2 The patients are cognitively normal and able to live and work independently.

3.1.3 Had adequate hearing, vision and comprehension and verbal expression to complete the cognitive assessments.

3.1.4 Had at least 3 years of education. 3.1.5 Signed informed consent.

3.2 The exclusion criteria of normal cognitive group: 3.2.1 The patients had no conditions known to affect cognitive function, such as vascular dementia, dementia with Lewy body dementia, frontotemporal dementia, Parkinson's disease, epilepsy, stroke, hydrocephalus, multiple sclerosis, traumatic brain injuries, genetic disorders affecting cognition, alcoholism, uncontrolled depression or other psychiatric disorders, Parkinson's disease, epilepsy or Alzheimer's disease.

3.2.2 Sequelae after previous history of severe central nervous system infection, multiple sclerosis, autoimmune encephalitis, Hashimoto's encephalopathy, etc.

3.2.3 Previous history of instable epilepsy. 3.2.4 Systemic diseases affect the CNS, for abnormal liver and kidney functions.

3.2.5 History of hereditary diseases that affect cognitive function (such as Huntington's disease, down syndrome, CADASIL, adrenal leukodystrophy, mitochondrial encephalopathy, etc.).

3.2.6 Infection and immune-related diseases affecting the central nervous system (systemic lupus erythematosus, undertreated HIV infection or a history of CNS syphilis infection, etc.).

3.2.7 Metabolic and endocrine disorders (requiring new treatment or adjustment of current treatment for thyroid dysfunction, folate or vitamin B12 deficiency).

3.2.8 Reject or had contraindications for MRI (e.g., pacemakers, stents, claustrophobia.).

Where this trial is running

Beijing, Beijing

• Beijing Tiantan Hospital，Capital Medical University — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: Shiping Li, Doctor

Conditions Cognitive Impairment; Alzheimer's disease; vascular cognitive impairment; dementia