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A multicenter, prospective study of TRPC6 in predicting clinical progression of the Alzheimer's disease continuum

A multicenter, prospective study of TRPC6 in predicting clinical progression of the Alzheimer's disease continuum

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300067889
Enrollment
Unknown
Registered
2023-01-30
Start date
2023-01-30
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Interventions

Case series:not applicable

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 85 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: The subjects must meet all the following conditions to be eligible to participate in this study: 1. Subjects are willing to participate, and those with cognitive impairment should jointly sign the informed consent form by their legal guardian. If the signature cannot be signed due to limited cognitive ability and other reasons, the signature of the subject is allowed to leave blank and explain the reasons. The legal guardian shall sign in the reason statement, and the legal guardian needs to sign an informed consent form; 2. Aged 45-85 years (including 45 and 85 years old), regardless of gender; 3. The chief complaint of memory loss is at least 12 months; 4. Primary school or above education level or equivalent ability, ability to complete the cognitive ability measurement and other tests specified in the program; 5. The total score of the Mini-Mental State Examination (MMSE) <= 26; 6. Complete the score of Clinical Dementia Rating (including CDR-Sum of box and global score), of which the CDR-global score is 0.5~1; 7. The total score of Hachinski Inchemic Scale (HIS) <= 4; 8. The total score of Hamilton Depression Scale -17 <= 7; 9. It can provide about 10 mL of blood; 10. Be able to complete routine imaging examinations, such as magnetic resonance scanning; 11. The Fazekas Scale grade of white matter damage on magnetic resonance imaging is not greater than 3; 12. Willing to accept one of the following two examinations: Positron Emission Tomography (PET) beta Amyloid protein imaging; Cerebrospinal fluid Alzheimer's disease biomarker examination. 13. The diagnostic standard of cognitive impairment adopts the National Institute on Aging-Alzheimer's Association (NIA-AA) 2011 standard; 14. Good compliance, willing to accept follow-up once a year for a total of 3 years.

Exclusion criteria

Exclusion criteria: Exclusion criteria: Subjects who meet any of the following conditions will not be able to participate in this study: 1. People with cognitive impairment caused by other reasons, including but not limited to: vascular dementia, central nervous system infections (such as AIDS, syphilis, etc.), Creutzfeldt-Jakob disease, Huntington's disease and Parkinson's disease, Lewy body dementia, brain traumatic dementia, other physical and chemical factors (such as drug poisoning, alcoholism, carbon monoxide poisoning, etc.), serious somatic diseases (such as hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial space occupying lesions (such as subdural hematoma, brain tumors), endocrine system lesions (such as thyroid disease, parathyroid disease), and dementia caused by vitamin B12, folic acid deficiency or any other known causes; 2. MRI examination showed significant focal lesions, including one of the following: (1) More than 2 infarcts with diameter greater than 2 cm; (2) There are infarctions in key parts such as thalamus, hippocampus, entorhinal cortex, paraolfactory cortex, angular gyrus, cortex and other subcortical gray matter nuclei; 3. There are uncorrectable visual and auditory disorders that cannot complete the neuropsychological test and scale assessment; 4. The examination required for the test cannot be completed due to its own reasons, such as contraindication of MRI scanning; 5. Those who cannot complete PET examination or cerebrospinal fluid examination; 6. Those who cannot complete venous blood collection; 7. Pregnant and lactating women (pregnancy is defined as positive urine pregnancy test); 8. Poor compliance; 9. The investigator determined that other conditions were not suitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
TRPC6 mRNA/Protein Level in blood;Amyloid-PET;Tau-PET;MRI;Plasma TRPC6 level;

Secondary

MeasureTime frame
ApoE genotype; Plasma Aß42/Aß40 level;Plasma NfL level;Plasma GFAP level;Plasma p-tau level;

Countries

China

Contacts

Public ContactYizheng Wang

Huashan Hospital, Fudan University

yzwang57@sina.com+86 13581537587

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026