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The Mechanism Study of Diabetic Pancreatic Amyloid Deposition on Cognitive Dysfunction in Alzheimer's Disease

China400 participantsStarted 2021-01-01

Plain-language summary

Alzheimer's disease (AD) is closely related to diabetes (DM). DM will aggravate the progression of AD, but the specific mechanism has not yet been clarified. Previous study found that a key pathological feature of the pancreas in patients with DM is islet amyloid polypeptide, and there is also islet amyloid polypeptide in the brain. Therefore, DM may cause cytotoxicity through the interaction between pancreatic amyloid and brain Aβ protein and further aggravate AD progress. In this study, starting with DM and AD pathological biomarkers, the amyloid PET target molecular probe 18F-AV45 will be used to monitor the dynamic changes of amyloid protein in the brain and pancreas during the development of AD. The completion of this study will provide a new view for understanding the mechanism of DM on AD cognitive dysfunction and effectively preventing and treating these two diseases.

Who can participate

Age range60 Years – 80 Years

SexALL

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Inclusion criteria

✓. Age between 60 and 80 years old; gender is not limited.
✓. The investigators have normal cognition and negative Aβ imaging through the test.
✓. Informed consent must be signed in writing by the subjects or their legal guardians and caregivers.
✓. Blood routine: white blood cell count (WBC) 4\~10×109/L; platelet (PLT) 100\~300×109/L; hemoglobin (HB) 120\~160 g/L; renal function: serum creatinine less than or equal to Upper limit of normal range; liver function: bilirubin, AST (SGOT)/ALT (SGPT) less than or equal to the upper limit of normal range; electrocardiogram: no significant abnormality.
✓. Willingness and ability to cooperate with all projects of this research.
✓. Age between 60 and 80 years old; gender is not limited.
✓. The diagnosis of AD was based on the 2011 National Association on Aging and Alzheimer's Disease (NIA-AA) diagnostic criteria for possible AD dementia. The diagnostic criteria for diabetes were based on the 1999 World Health Organization (WHO) diagnostic criteria for diabetes.
✓. Brain MRI supports the diagnosis of AD, and there is no evidence of other neurological diseases.

Exclusion criteria

What they're measuring

Complete PET imaging

Timeframe: 50mins from time of injection

Trial details

NCT IDNCT05372458

SponsorHuashan Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-31

Contact for this trial

Donglang Jiang, MD

+86-13795345740 dljiang16@fudan.edu.cn

View on ClinicalTrials.gov More AD trials