Methylphenidate and Cognitive Training in Elderly

Last updated: December 4, 2025
Sponsor: University Hospital, Lille
Overall Status: Completed

Phase

2

Condition

Mental Disability

Memory Loss

Healthy Volunteers

Treatment

Methylphenidate

CogniPlus software

Pseudo cognitive training

Clinical Study ID

NCT03280251
2015_81
2016-005131-32
  • Ages 55-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Currently, there is no available drug to treat the symptoms of neurodegenerative and vascular cognitive disorders that affect millions of people worldwide.

Methylphenidate is indicated at high dose (1 mg/kg/day) in children having attention deficit and hyperactivity disorder (ADHD) and remains the best cognitive enhancer drug at lower dose. However, there is no proof of efficacy with chronic administration, outside ADHD, and concern remains about long-term cardiac and vascular risks in elderly and particularly in population with vascular risk factors and drug abuse in young people. Moreover, the effect appears to be very limited at the very advanced stage of dementia, for which the neuronal plasticity is too reduced to expect a benefit of training.

Taken all together, we sought to develop a new paradigm of association of both pharmacological and non-pharmacological procedure to enhance the neuronal plasticity in order to expect a persistent effect on slight to mild cognitive disorders with benefit on ecological test (i.e. driving). Finally, short-term treatment would reduce the safety concerns.

The concept will be to prove that low dose of methylphenidate associated with active cognitive training during 6 weeks can improve the cognitive function in healthy aged volunteers with a persistent effect at 3 months.

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

Total Participants: 31
Treatment Group(s): 4
Primary Treatment: Methylphenidate
Phase: 2
Study Start date:
September 19, 2018
Estimated Completion Date:
March 11, 2020

Connect with a study center

  • Hôpital Roger Salengro, CHU

    Lille 2998324,
    France

    Site Not Available

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