Phase
Condition
Mental Disability
Memory Loss
Healthy Volunteers
Treatment
Methylphenidate
CogniPlus software
Pseudo cognitive training
Clinical Study ID
Ages 55-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Without severe chronic neurological or mental or psychiatric pathology
Absence of cognitive impairment affecting autonomy (scores on the dementia scale ofMattis> 130 and the IADL = 4)
Right-handed participant
Subjects holding driving license B and continuing a driving activity
Affiliate or beneficiary of a social security scheme
Subject having signed informed consent
Subject having agreed to be registered on the National File of Healthy Volunteers
Patient willing to comply with all procedures of the study and its duration
No planned changes in lifestyle (nutritional and physical, social interactions)during the life of the protocol
Exclusion
Exclusion Criteria:
Administrative reasons: impossibility of receiving informed information, inabilityto participate in the whole study, absence of coverage by the social securitysystem, refusal to sign consent.
Subject simultaneously participating in another clinical trial or in an exclusionperiod.
Subject under tutelage or curatelle.
Subject during breastfeeding or pregnancy.
Subject not sufficiently fluent in the French language to understand theinstructions necessary to carry out the cognitive tests.
Subject with uncorrected visual pathology or motor pathology (orthopedic example)likely to interfere with the passing of tests.
Subject with dependencies pre-existing to medicines, drugs or alcohol.
Presence of contraindications to MRI: Claustrophobia, Anxiety crisis, Morphotype notallowing access to MRI, metal implant (eg a pacemaker), surgical clipsFerromagnetic, orbital or brain metallic foreign bodies).
Hypersensitivity to methylphenidate or any other constituents of the product.
Subject with a personal and / or family history of motor tics and Gilles de laTourette syndrome.
Subjects with a previous psychiatric history (based on the semi-structuredpsychiatric interview with the MINI of DSM IV adapted to DSM V): state, severedepression, severe generalized anxiety, anorexia nervosa or anorexic disorders,suicidal tendencies, psychotic symptoms, severe mood disorders, mania,schizophrenia, psychopathic personality disorder or borderline disorder. Dysthymiaand an isolated history of depression do not constitute an exclusion criterion.
Subjects consuming one or more psychotropic drugs or related products (antidepressants, antipsychotics, antiepileptic drugs, daily use of benzodiazepineanxiolytics or other anxiolytics, vesperal hypnotic intake). A history of takingpoint hypnotics is not a criterion of exclusion. However, there should be no regularand regular intake in the previous 3 months and less than once a week (ideally, lackof intake would be desirable but would considerably limit the potential forinclusion). They will be asked not to change their habits during the study period.
Subjects with dysthyroidism or thyrotoxicosis
Subjects with pre-existing cardiovascular disorders including severe hypertension,heart failure, occlusive arterial disease, angina pectoris, congenital heart diseasewith hemodynamic repercussions, cardiomyopathy, myocardial infarction, arrhythmiasand channelopathies
Subject with angle-closure glaucoma.
Significant abnormalities on MRI and EEG according to the investigator's judgment
Presence of untreated hypertension discovered during screening
Subject with pheochromocytoma
Pre-existing cerebrovascular disorders, cerebral aneurysm, vascular abnormalities,including vasculitis or stroke in the subject
Subjects with hepatic and renal insufficiency
Obese subject according to WHO classification (BMI> 30)
Presence of one of the following treatments that cannot be stopped for a periodcorresponding to 5 half-lives before inclusion: selective and non-selective MAOIs (nialamide and iproniazide, selegiline), other indirect sympathomimetics (phenylpropanolamine, pseudoephedrine, Phenylephrine), halogenated volatileanesthetics, guanethidine and related compounds.
Treatment with alpha sympathomimetics (oral and / or nasal route) (etilefrin,midodrine, naphazoline, oxymetazoline, tetryzoline, tuaminoheptane, tymazoline),opiates and morphine derivatives. These concomitant treatments are contraindicatedat baseline and throughout the study period.
Subject with leukopathy classified ≥2 on the Fazekas scale
Study Design
Connect with a study center
Hôpital Roger Salengro, CHU
Lille 2998324,
FranceSite Not Available

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