Metabolic risk factors defined by ATP-III-criteria Amyloid deposition as indication of preclinical Alzheimer’s disease
Conditions
Interventions
Group 1: Experimental group with amyloid deposition. Subjects in this group show amyloid depositions in an amyloid-PET scan. PET is performed prior to training and is used for subjects´ group allocati
Sponsors
Deutsches Zentrum für Neurodegenerative Erkrankungen e.V.
Eligibility
Sex/Gender
All
Age
65 Years to 75 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in brain glucose-metabolism (Glucose-PET; befor and after 4 months of training - visit 3 and 5) Change in pattern separation in memory (Rey/Taylor Complex-Figure Test; visit 3, 5 and 6 - 14 month after the training) Change in hippocampal perfusion (ASL-MRI; visit 3, 5 and 6) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in functional pattern separation in the hippocampus (fMRI; visit 3, 5 und 6) Change in peripheral (serum) indices of plasticity and insulin signaling (e.g., BDNF, IGF, VEGF; visit 3, 4 - 2 months after start of the training - and 5), immune cell phenotyping (visit 3, 4, 5 and 6), as well as important plasticity relevant proteins (Cathepsin B, Klotho; visit 3, 4 and 5) Exploratory analyses: Mobile assessment of pattern separation and pattern completion (visit 2 - max 3 months before start of the training -, 3, 4, 5 and 6) Epigenetic reprogramming (serum; visit 3, 4 and 5) Proprioception (Monofilament; visit 3) temperature perception (tip-therm; visit 3) peripheral sensitivity (visit 3) Clinical, functional and cognitive examinations (GDS, NPI-Q, GAI, Major Depression Episode, Mini Mental Status Exemption (MMSE), FAQ, CDR, PACC, TMT A & B, MWT-B, ECOG- and Nutrition Questionnaire; visit 3, 5 and 6) effects on the coordination of foot movements (smart insole with embedded pressure sensors; visit 3) Osmolality (serum; visit 3, 5 and 6) urine samples (visit 3 and 5) | — |
Countries
Germany
Contacts
Public ContactAnne Hochkeppler
Deutsches Zentrum für Neurodegenerative Erkrankungen e.V. (DZNE Magdeburg)
Outcome results
None listed