Healthy VolunteersPhase 2PACTE-1NCT03280251
Methylphenidate and Cognitive Training in Elderly
A Phase 2 study testing Methylphenidate, CogniPlus software and Pseudo cognitive training in people with Healthy Volunteers, run by University Hospital, Lille at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Methylphenidate, CogniPlus software and Pseudo cognitive training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2018to 11 Mar 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read more
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.
- Conditions
- Healthy Volunteers
- Being tested
- Methylphenidate, Placebo, CogniPlus software, Pseudo cognitive training
- Keywords
- Cognitive disorders, cognitive training, symptomatic treatment, Methylphenidate, elderly
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Methylphenidate (capsules of Ritaline LP 10) encapsulated, 0,3 mg per kg per day during 6 weeks
PlaceboDrug
Placebo, identical capsules to encapsulated MPH, number of capsules per day identical to MPH during 6 weeks
CogniPlus softwareOther
Structured cognitive training with CogniPlus software, twice per week during 6 weeks
Pseudo cognitive trainingOther
Pseudo cognitive training with 45 minutes documentary videos and 15 minutes quiz, twice per week during 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate and structured cognitive training | Experimental | Methylphenidate (capsules of Ritaline LP 10) encapsulated, 0,3 mg per kg per day during 6 weeks Structured cognitive training with CogniPlus software, twice per week during 6 weeks Receives: Drug: Methylphenidate; Other: CogniPlus software |
| Placebo and structured cognitive training | Experimental | Placebo, identical capsules to encapsulated MPH, number of capsules per day identical to MPH during 6 weeks Structured cognitive training with CogniPlus software, twice per week during 6 weeks Receives: Drug: Placebo; Other: CogniPlus software |
| Methylphenidate and pseudo cognitive training | Experimental | Methylphenidate (capsules of Ritaline LP 10) encapsulated, 0,3 mg per kg per day during 6 weeks Pseudo cognitive training with 45 minutes documentary videos and 15 minutes quiz, twice per week during 6 weeks Receives: Drug: Methylphenidate; Other: Pseudo cognitive training |
| Placebo and pseudo cognitive training | Experimental | Placebo, identical capsules to encapsulated MPH, number of capsules per day identical to MPH during 6 weeks Pseudo cognitive training with 45 minutes documentary videos and 15 minutes quiz, twice per week during 6 weeks Receives: Drug: Placebo; Other: Pseudo cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of the average response time to a choice task at inclusion and at the end of treatment (after 6 weeks)
Measured: 6 weeks after the beginning of the treatment
Secondary outcomes (8)
Change from baseline the composite cognitive functions
A composite measure of several cognitive functions: attention, executive functions, working memory, verbal and nonverbal episodic memory, visuo-spatial functions
Measured: Baseline, at 6 weeks, at 12 weeks
Change from baseline of the results to task on a driving simulator
A composite measure of task on a driving simulator: travel time, speed parameters(average speed, maintaining the target speed) compliance with the instructions and code of the road (number and type of errors), number of cars doubled, reaction time in analytics.
Measured: Baseline, at 6 weeks, at 12 weeks
Behavior Rating Inventory of Executive Function (BRIEF-A)
Measured: Baseline, at 6 weeks, at 12 weeks
Hospital Anxiety and Depression scale (HAD)
Measured: Baseline, at 6 weeks, at 12 weeks
Number of undesirable effects of treatment
Measured: at 2 weeks, at 4 weeks, at 6 weeks, at 12 weeks
Change from baseline the parameters of structured cognitive training (CogniPlus®)
A composite measure of parameters following : processing speed, inhibition and working memory resources.
Measured: Baseline, at 6 weeks, at 12 weeks
Resting state EEG
EEG with Attentional Network Test and Go / No Go task
Measured: Baseline, at 6 weeks, at 12 weeks
resting state functional MRI
The changes of resting state functional MRI after treatment and cognitive training
Measured: Baseline, at 6 weeks, at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start19 Sep 2018
- Primary completion11 Mar 2020
- Study completion11 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Devos, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280251
- Sponsor's protocol ID
- 2015_81
- Other IDs
- 2016-005131-32, 2016
- Acronym
- PACTE-1
- Status last verified
- Nov 2023
- First submitted
- 5 Sep 2017
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03280251
- Acronym / sponsor ID
- PACTE-1 / 2015_81
- Conditions
- Healthy Volunteers
- Keywords
- Cognitive disorders, cognitive training, symptomatic treatment, Methylphenidate, elderly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate and structured cognitive training | Experimental | Drug: Methylphenidate, Other: CogniPlus softwareMethylphenidate (capsules of Ritaline LP 10) encapsulated, 0,3 mg per kg per day during 6 weeks Structured cognitive training with CogniPlus software, twice per week during 6 weeks |
| Placebo and structured cognitive training | Experimental | Drug: Placebo, Other: CogniPlus softwarePlacebo, identical capsules to encapsulated MPH, number of capsules per day identical to MPH during 6 weeks Structured cognitive training with CogniPlus software, twice per week during 6 weeks |
| Methylphenidate and pseudo cognitive training | Experimental | Drug: Methylphenidate, Other: Pseudo cognitive trainingMethylphenidate (capsules of Ritaline LP 10) encapsulated, 0,3 mg per kg per day during 6 weeks Pseudo cognitive training with 45 minutes documentary videos and 15 minutes quiz, twice per week during 6 weeks |
| Placebo and pseudo cognitive training | Experimental | Drug: Placebo, Other: Pseudo cognitive trainingPlacebo, identical capsules to encapsulated MPH, number of capsules per day identical to MPH during 6 weeks Pseudo cognitive training with 45 minutes documentary videos and 15 minutes quiz, twice per week during 6 weeks |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylphenidateMethylphenidate (capsules of Ritaline LP 10) encapsulated, 0,3 mg per kg per day during 6 weeks | Drug | Methylphenidate and pseudo cognitive training, Methylphenidate and structured cognitive training |
| PlaceboPlacebo, identical capsules to encapsulated MPH, number of capsules per day identical to MPH during 6 weeks | Drug | Placebo and pseudo cognitive training, Placebo and structured cognitive training |
| CogniPlus softwareStructured cognitive training with CogniPlus software, twice per week during 6 weeks | Other | Methylphenidate and structured cognitive training, Placebo and structured cognitive training |
| Pseudo cognitive trainingPseudo cognitive training with 45 minutes documentary videos and 15 minutes quiz, twice per week during 6 weeks | Other | Methylphenidate and pseudo cognitive training, Placebo and pseudo cognitive training |
Primary outcome
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
8 secondary outcomes
Change from baseline the composite cognitive functions
Time frame: Baseline, at 6 weeks, at 12 weeks
Change from baseline of the results to task on a driving simulator
Time frame: Baseline, at 6 weeks, at 12 weeks
Behavior Rating Inventory of Executive Function (BRIEF-A)
Time frame: Baseline, at 6 weeks, at 12 weeks
Hospital Anxiety and Depression scale (HAD)
Time frame: Baseline, at 6 weeks, at 12 weeks
Number of undesirable effects of treatment
Time frame: at 2 weeks, at 4 weeks, at 6 weeks, at 12 weeks
Change from baseline the parameters of structured cognitive training (CogniPlus®)
Time frame: Baseline, at 6 weeks, at 12 weeks
Resting state EEG
Time frame: Baseline, at 6 weeks, at 12 weeks
resting state functional MRI
Time frame: Baseline, at 6 weeks, at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Devos, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methylphenidate, CogniPlus software and Pseudo cognitive training in people with Healthy Volunteers, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.