PACTE-1

CompletedPhase 2

Methylphenidate and Cognitive Training in Elderly

Potentiation of Cognitive Functions in Healthy Elderly by Association of Methylphenidate and Cognitive Training: Proof of Concept Study in Order to Develop a Synergic Symptomatic Treatment for the Cognitive Disorders Before Dementia

Lead sponsor

University Hospital, Lille

Asset

Methylphenidate

Listed sites

Recruiting sites

Enrollment

actual

Study population

Mixed / unspecified dementia

Key I/E criteria

•Healthy volunteers•MRI contraindications excluded

Primary endpoint

•The average response time to a choice task at inclusion

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID2015_81

Eudract number2016-005131-32

NCT IDNCT03280251

Timeline

Milestones

Study first posted2017-09-12actual

Study start2018-09-19actual

Primary completion2020-03-11actual

Study completion2020-03-11actual

Last update posted2025-12-11actual

Assets

Drug assets

Methylphenidate

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age55 Years

Maximum age75 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Without severe chronic neurological or mental or psychiatric pathology

•Absence of cognitive impairment affecting autonomy (scores on the dementia scale of Mattis> 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 criteria

•Administrative reasons: impossibility of receiving informed information, inability to participate in the whole study, absence of coverage by the social security system, refusal to sign consent.

•Subject simultaneously participating in another clinical trial or in an exclusion period.

•Subject under tutelage or curatelle.

•Subject during breastfeeding or pregnancy.

•Subject not sufficiently fluent in the French language to understand the instructions 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 not allowing access to MRI, metal implant (eg a pacemaker), surgical clips Ferromagnetic, 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 la Tourette syndrome.

•Subjects with a previous psychiatric history (based on the semi-structured psychiatric interview with the MINI of DSM IV adapted to DSM V): state, severe depression, severe generalized anxiety, anorexia nervosa or anorexic disorders, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic personality disorder or borderline disorder. Dysthymia and 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 benzodiazepine anxiolytics or other anxiolytics, vesperal hypnotic intake). A history of taking point hypnotics is not a criterion of exclusion. However, there should be no regular and regular intake in the previous 3 months and less than once a week (ideally, lack of intake would be desirable but would considerably limit the potential for inclusion). 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 disease with hemodynamic repercussions, cardiomyopathy, myocardial infarction, arrhythmias and 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 period corresponding to 5 half-lives before inclusion: selective and non-selective MAOIs (nialamide and iproniazide, selegiline), other indirect sympathomimetics (phenylpropanolamine, pseudoephedrine, Phenylephrine), halogenated volatile anesthetics, 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 contraindicated at baseline and throughout the study period.

•Subject with leukopathy classified ≥2 on the Fazekas scale

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Memory

Executive function / language

Behavior / neuropsychiatric

Neuroimaging

Fluid / digital biomarkers

Memory

2 endpoints

Secondary/protocol endpoint

Change from baseline the composite cognitive functions

Time frame:Baseline, at 6 weeks, at 12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline the parameters of structured cognitive training (CogniPlus®)

Time frame:Baseline, at 6 weeks, at 12 weeks

change from baseline, improvement

Executive function / language

1 endpoint

Secondary/protocol endpoint

Behavior Rating Inventory of Executive Function (BRIEF-A)

Time frame:Baseline, at 6 weeks, at 12 weeks

descriptive

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Hospital Anxiety and Depression scale (HAD)

Time frame:Baseline, at 6 weeks, at 12 weeks

descriptive

Neuroimaging

1 endpoint

Secondary/protocol endpoint

resting state functional MRI

Time frame:Baseline, at 6 weeks, at 12 weeks

descriptive

Fluid / digital biomarkers

1 endpoint

Secondary/protocol endpoint

Resting state EEG

Time frame:Baseline, at 6 weeks, at 12 weeks

descriptive

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

The difference of the average response time to a choice task at inclusion and at the end of treatment (after 6 weeks)

Time frame:6 weeks after the beginning of the treatment

time to event, event

Secondary/protocol endpoint/low confidence

Change from baseline of the results to task on a driving simulator

Time frame:Baseline, at 6 weeks, at 12 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Number of undesirable effects of treatment

Time frame:at 2 weeks, at 4 weeks, at 6 weeks, at 12 weeks

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.