No medical condition is under investigation. The project investigates normal age-related decline in intellectual abilities.
Conditions
Interventions
Trade Name: Madopark Quick
Pharmaceutical Form: Tablet
Sponsors
Aging Research Center, Karolinska Institutet and Stockholm University
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate effects of enhanced dopaminergic neurotransmission on efficiency of working memory training for improving fluid intelligence (reasoning).;Secondary Objective: To study effects of enhanced dopaminergic neurotransmission on efficiency of working memory training for improving episodic memory, creativity, switching and updating performance. To study effects of dopamine-enhanced working memory training on structural and functional brain connectivity. To investigate effects of dopamine-enhanced working memory training on plasma and CSF markers of brain plasticity (e.g. BDNF), dopamine metabolism (e.g. homovanillic acid, monoamine oxidase) and neurodegeneration (e.g. tau, p-tau, Abeta).;Primary end point(s): Fluid intelligence defined by multi-test latent composite scores as follows: - Spatial Intelligence (BETA-III, WASI-II, Raven's matrices) - Verbal Intelligence (BIS analogies, Syllogisms, ETS Kit inference) ;Timepoint(s) of evaluation of this end point: During week 8 (visits 29-33) and week 35 (visits 36-40), compared to baseline week 2 (visits 3-7). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Multi-test latent composite scores of performance on tasks measuring episodic memory, creativity, switching and updating performance. 2. Functional (measured with functional magnetic resonance imaging) and structural (measured with diffusion-tensor imaging) connectivity within the fronto-parietal and fronto-subcortical circuits and cortical thickness within the fronto-parietal network. 3. Plasma and CSF markers of plasticity (e.g. DNF), dopamine metabolism (e.g. homovanillic acid, monoamine oxidase) and neurodegeneration (e.g.tau, p-tau, Abeta).;Timepoint(s) of evaluation of this end point: 1. During week 8 (visits 29-33) and week 35 (visits 36-40), compared to baseline week 2 (visits 3-7). 2. During week 9 (visit 34), compared to baseline week 3 (visit 8). 3. Plasma levels will be evaluated during week 7 (visit 28), compared to baseline week 4 (visit 9). CSF levels will be evaluated during week 9 (visit 35). | — |
Countries
Sweden
Contacts
Public ContactMarie Helsing
Aging Research Center, Karolinska Institutet and Stockholm University
Outcome results
None listed