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临床试验/DRKS00013501
DRKS00013501尚未招募未知

Metabolic and neurovascular brain plasticity in amyloid-positive older people with metabolic risk factors - EnergI

Deutsches Zentrum für Neurodegenerative Erkrankungen e.V.0 个研究点目标入组 300 人开始时间: 2017年12月15日最近更新:
适应症

试验速览

阶段
未知
状态
尚未招募
入组人数
300

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
65 Years 至 75 Years(—)
性别
All

入选标准

  • Body Mass Index = 25 to max. 40 kg / m2
  • - Presence of at least one metabolic risk factor (according to ATP III criteria (National Cholesterol Education Program (NCEP): Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (ATP III Final Report), 2002 )
  • Abdominal obesity, determined by a waist circumference of over 102 cm in men or over 88 cm in women
  • Fasting triglycerides greater than 150 mg/dl (> 1.7 mmol/l), or already initiated therapy to reduce triglycerides
  • HDL cholesterol = 40 mg/dl (<1.05 mmol/l) in men or <50 mg/dl (1.25 mmol/l) in women
  • Blood pressure of 130/85 mmHg or higher, or already initiated therapy to reduce hypertension
  • Fasting glucose = 110 mg/dl (5.6 mmol/l)
  • - Written declaration of consent for PET measurements with [18F]-FDG and [18F]-Florbetaben
  • - Preserved legal capacity of the subjects at the time of each examination

排除标准

  • - Coronary heart disease in all manifestations
  • - Cardiomyopathies
  • - Supraventricular and ventricular arrhythmias
  • - Clinically relevant cardiac defects
  • - Blood pressure above 140/90 mmHg
  • - heart insufficiency > stage IIb according to NYHA
  • - Severe chronic obstructive pulmonary disease (COPD), bronchial asthma
  • - Resting bradycardia (below 45 bpm)
  • - Relevant orthopedic diseases
  • - Serious internal diseases
  • - MRI disqualification(claustrophobia, pacemakers, metallic endoprostheses)
  • - Severe vision or hearing impairments (uncorrected)
  • - Body mass index >40 or <25 kg/m2
  • - Current major depressive disorder and / or severe neuropsychological disorder
  • - Current severe neurological disease of the central nervous system
  • - Current dependence (e.g. alcohol, psychoactive pharmaceuticals, cocaine, heroin)
  • - Acute viral or bacterial infection
  • - Intake of antidiabetics
  • - Diabetes mellitus
  • - Regular intake of benzodiazepines
  • - Incapable of doing sports
  • - Foot deformities of any kind
  • - Persons for whom radioactive substances or ionizing radiation have been used for research or treatment purposes in the past ten years (§88 (2) Radiation Protection Ordinance), excluding purely diagnostic examinations
  • - Serious liver disease (e.g. chronic hepatitis, cirrhosis of the liver) or renal dysfunction requiring dialysis
  • - History of stroke or epilepsy

研究者

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