REBOOT: Releasing the brakes on adult plasticity

Phase 1

• Conditions: o medical condition is under investigation. The project investigates normal age-related decline in intellectual abilities.; Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

• Registration Number: EUCTR2016-000891-54-SE
• Lead Sponsor: Aging Research Center, Karolinska Institutet and Stockholm University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-05
• Last Update Posted: 19 March 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Mini-Mental State Examination score >26;
• Aged between 65 and 75 years;
• Absence of medical or psychiatric conditions specified in the exclusion criteria;
• Signed informed consent;
• Right handedness;
• Fluent Swedish;
• Absence of colorblindness;
• No previous participation in studies of similar design;
• No trauma to the head with loss of consciousness for more than 10 min;
• No history of brain injuries;
• No hormonal imbalance diseases (e.g. Cushing’s syndrome);

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

• Glaucoma (any history);
• Any history of serious heart disease (myocardial infarction, arrhythmia, atrioventricular block);
• Serious problems with heart and blood vessels, systolic/diastolic blood pressure < 100/50 or >160/95; Heart Failure: NYHA > IB; Chronic Venous Disease CEAP > C2);
• Severe pulmonary diseases;
• Type I diabetes;
• Recent history (5 years) of stomach and duodenum ulcers;
• Liver diseases (e.g. hepatitis, liver failure);
• Bleeding of the stomach or intestines;
• Kidney diseases;
• Serious urination problems;
• Recent history (5 years) of malignant tumor or mole, melanoma;
• Major psychiatric disorders such as major depression, bipolar affective disorder, psychosis (risks of exacerbation of psychiatric symptoms). History of mild to moderate depression/anxiety is allowed (but not recent: 5 year cut-off);
• Patients with neurological (Parkinson's and other movement disorders, Alzheimer's disease, epilepsy) disorders will also be excluded, as the present project targets healthy elderly population;
• MRI contra-indications: metal body implants and pacemakers, cochlear implants, claustrophobia, weight over 120 kg;
• Hypersensitivity to pro-dopaminergic drugs;
• Hypersensitivity to citrus fruits/ascorbic acid;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified