AzTrials
AzTrials

ADNCT05372458

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

An observational study of AD and DM, run by Huashan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 60 to 80 yearsHealthy volunteers can take part
Conditions the study is for
AD, DM, PET-CT
How many people
400 participants
Where
1 siteChina
Study dates
1 Jan 2021to 31 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: clinical or community

Who may be able to join

  • Non-disease controls:
  • 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.
Show all 14Show fewer
  • AD patients/DM patients:
  • 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.
  • No neurological disease, major chronic disease, malignant tumor or acute infectious disease has been confirmed by the investigator.
  • An informed consent form 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; 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.

Who cannot join

  • Subjects meeting any of the following criteria will be excluded from the study:
  • Suffering from other serious neurological diseases, or gastrointestinal, cardiovascular, liver, kidney, blood system, tumor endocrine, respiratory system, immune deficiency and other serious diseases.
  • Candidate subjects have contraindications to PET/CT scanning. Those who cannot accept repeated intravenous injections; those who may be allergic to drugs and their components (including a history of severe allergy or allergic reactions, especially those who are allergic to the tested drugs); phobia of tightness.
  • In the past year, in addition to participating in the expected radiation exposure of this clinical study, have participated in other research programs or clinical care, resulting in radiation exposure exceeding the effective dose of 50 mSv.
  • Drug or alcohol abuse for at least 1 month.
  • The venous condition is poor and cannot tolerate repeated venipuncture.
  • The candidate subject has received major surgery within the past 3 months; received experimental drug or device treatment (with unclear effect or safety) within 1 month
  • The candidate subjects have any clinical conditions that the host of this study believes that this preparation may cause or have potential harm.

Trial locations and contacts

1 site in 1 country.

Donglang Jiang, MD contact

+86-13795345740

dljiang16@fudan.edu.cn

China1 site, 1 recruiting

  • Huashan Hospital

    Shanghai, 200040

    Yihui Guan, MD, +86-13764308300, guanyihui@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: The Mechanism Study of Diabetic Pancreatic Amyloid Deposition on Cognitive

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.

Read the detailed description

This is a single-center, prospective, and observational study, which mainly focuses on the interaction between pancreatic amyloid and brain Aβ protein and further aggravates AD progress in China. PET imaging will be used on subjects. Previously collected patient data may also be enrolled in this study.

Conditions
AD, DM, PET-CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete PET imaging

    Assessment of PET/CT imaging to detect abeta in patients with AD and DM

    Measured: 50mins from time of injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2022
  2. Study start1 Jan 2021
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05372458
Sponsor's protocol ID
KY2021-007
Status last verified
May 2022
First submitted
8 May 2022
Last updated
12 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of AD and DM, run by Huashan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Donglang Jiang, MD (+86-13795345740, dljiang16@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete PET imaging (time frame: 50mins from time of injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05372458.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in