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

Not Applicable
Conditions
Metabolic risk factors defined by ATP-III-criteriaAmyloid deposition as indication of preclinical Alzheimer’s disease
Registration Number
DRKS00013501
Lead Sponsor
Deutsches Zentrum für Neurodegenerative Erkrankungen e.V.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
300
Inclusion Criteria

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

Exclusion Criteria

- 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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in brain glucose-metabolism (Glucose-PET; befor and after 4 months of training - visit 3 and 5)<br>Change in pattern separation in memory (Rey/Taylor Complex-Figure Test; visit 3, 5 and 6 - 14 month after the training)<br>Change in hippocampal perfusion (ASL-MRI; visit 3, 5 and 6)<br>
Secondary Outcome Measures
NameTimeMethod
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