Observational study on Alzheimer's disease and dementia biomarkers

Neurovascular Coupling and Digital Biomarkers in Alzheimer's Disease

This study is trying to find important signs in the brain and blood that can help us understand how Alzheimer's disease develops in both people with memory problems and healthy volunteers.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 50 Years to 90 Years
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05623124 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate neuroimaging and biomarkers in the Alzheimer's disease continuum. Participants, including those with cognitive impairment and healthy volunteers, will undergo annual assessments involving multi-modal MRI, PET scans, neuropsychological tests, and blood tests. The study focuses on understanding neurovascular coupling during Alzheimer's pathogenesis and mapping alterations in AD biomarkers. By building a cohort of aging individuals, the researchers hope to uncover significant biomarkers that could enhance understanding of Alzheimer's disease progression.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 50 to 90 years with mild cognitive impairment or dementia as per established diagnostic criteria.

Not a fit: Patients with cognitive decline due to other neurological conditions or systemic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and early detection of Alzheimer's disease through the identification of key biomarkers.

How similar studies have performed: Other studies have shown promise in identifying biomarkers for Alzheimer's disease, making this approach both relevant and potentially impactful.

Eligibility criteria

Inclusion Criteria:

1. Male and female aged 50 to 90 years old;
2. In accordance with the diagnostic criteria for "mild cognitive impairment due to Alzheimer's disease" and "Dementia" from the National Institutes of Health National Institute on Aging-Alzheimer's Association (NIA-AA) (2011);
3. The Hamilton depression rating scale/17 edition (HAMD) total score\<10;
4. The clinical dementia rating (CDR) is 0.5 or above;
5. Neurological examination: no obvious signs;
6. Participants should have a caregiver stable and reliable.
7. Education: primary school (grade 6) or above. They have the ability to complete tests for cognitive ability and have the ability and time to complete regulation of cognitive training

Exclusion Criteria:

1. Other causes of cognitive decline: cerebrovascular disease, central nervous system infection, CJD, Huntington's and Parkinson's disease, DLB, traumatic brain dementia, other physical and chemical factors (such as drugs, alcohol, CO), systemic disease (hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial occupation (a subdural hematoma, brain tumor), the endocrine system disease (thyroid disease, parathyroid disease), and vitamins deficiency or any other causes of dementia.
2. The history of nervous system diseases, including stroke, optic myelitis, Parkinson's disease, epilepsy, etc.);
3. Psychiatric patients, including schizophrenia or other mental illnesses, bipolar disorder, major depression, or delirium;
4. There are unstable or serious heart, lung, liver, kidney, and hematopoietic system diseases; Poor prognosis because of malignant diseases such as tumors.
5. Vision or hearing problems that lead to poor performance on cognitive tests;
6. Two years history of severe alcoholism, and drug abuse;
7. The researchers believe that the subjects could not complete the study.
8. Contraindication of MRI or PET scanning.

Where this trial is running

Shanghai, Shanghai Municipality

• Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)

Conditions Dementia