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临床试验/NCT07482072
NCT07482072招募中不适用

Imaging Biomarkers in Alzheimer's Disease - an Exploratory PET Study

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Glucose transport

研究概览

简要总结

Alzheimer's disease is the most common cause of dementia and affects a growing number of older adults. Although harmful proteins build up in the brain, we still do not fully understand why some brain regions are affected earlier or more severely than others. Many people with Alzheimer's disease also have problems with blood flow and sugar handling in the brain, and these changes may play an important role in disease development. People with type 2 diabetes are at especially high risk of developing Alzheimer's disease and often experience a more severe disease course.

This pilot study aims to improve our understanding of how brain blood flow and sugar use are altered in Alzheimer's disease, and whether these changes differ in people with and without type 2 diabetes. We will study three groups: people with Alzheimer's disease without diabetes, people with Alzheimer's disease and type 2 diabetes, and healthy older individuals. By comparing these groups, we aim to identify early brain changes that may contribute to cognitive decline.

Participants will undergo advanced brain imaging using positron emission tomography (PET) scans. One scan uses a radioactive sugar tracer to measure how the brain takes up and uses glucose. Importantly, a new non-invasive method will also allow us to estimate how efficiently glucose is transported from the blood into the brain. This is a key process that may be impaired in Alzheimer's disease, but has previously required invasive procedures. The new approach avoids arterial cannulation, making the study safer and more comfortable for participants.

A second PET scan will assess brain blood flow and blood vessel function, including how well the vessels can respond to increased demand. Participants will also complete cognitive tests to assess memory and thinking abilities.

Ultimately, this research may contribute to earlier diagnosis, better monitoring of disease progression, and development of new treatment strategies for Alzheimer's disease.

详细描述

  1. Synopsis / Summary

Design: Comparative imaging study.

Population: 60 participants:

Group A: 20 patients with suspected Alzheimer's disease (AD) without type 2 diabetes (T2D)

Group B: 20 patients with suspected AD + T2D

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
60 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • suspected Alzheimer's disease
  • type 2 diabetes (group A)
  • able and willing to comply with study protocoil´´l

排除标准

  • type 2 diabetes (group B and C)
  • significant brain disease apart from dementia (group A and B)
  • significant vascular or neurological disease (group C)
  • active cancer treatment
  • history of alcohol or drug abuse
  • severe claustrophobia
  • pregnancy or breastfeeding

研究组 & 干预措施

Alzheimer's disease with type 2 diabetes

Suspected Alzheimer's disease combined with type 2 diabetes

干预措施: [18F]FDG PET (Diagnostic Test)

Alzheimer's disease with type 2 diabetes

Suspected Alzheimer's disease combined with type 2 diabetes

干预措施: [11C]PIB (Diagnostic Test)

Alzheimer's disease without type 2 diabetes

Suspected Alzheimer's disease. No diagnosis of type 2 diabetes

干预措施: [18F]FDG PET (Diagnostic Test)

Alzheimer's disease without type 2 diabetes

Suspected Alzheimer's disease. No diagnosis of type 2 diabetes

干预措施: [11C]PIB (Diagnostic Test)

Healthy subjects

Age-matched subjects with no major vascular or neuroological diseses

干预措施: [18F]FDG PET (Diagnostic Test)

Healthy subjects

Age-matched subjects with no major vascular or neuroological diseses

干预措施: [11C]PIB (Diagnostic Test)

结局指标

主要结局

Glucose transport

时间窗: at inclusion

Regional flux of glucose to brain regions, (mmol/mL/min )

次要结局

  • Glucose metabolism(at inclusion)
  • Amyloid load(at inclusion)
  • Stress perfusion(at inclusion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lisbeth Marner

Professor

Copenhagen University Hospital at Herlev

研究点 (1)

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