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
Overview
- Phase
- Phase 2
- Intervention
- CogniPlus software
- Conditions
- Healthy Volunteers
- Sponsor
- University Hospital, Lille
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- The difference of the average response time to a choice task at inclusion and at the end of treatment (after 6 weeks)
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Placebo and structured cognitive training
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
Intervention: CogniPlus software
Methylphenidate and structured cognitive training
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
Intervention: Methylphenidate
Methylphenidate and structured cognitive training
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
Intervention: CogniPlus software
Placebo and structured cognitive training
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
Intervention: Placebo
Methylphenidate and pseudo cognitive training
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
Intervention: Methylphenidate
Methylphenidate and pseudo cognitive training
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
Intervention: Pseudo cognitive training
Placebo and pseudo cognitive training
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
Intervention: Placebo
Placebo and pseudo cognitive training
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
Intervention: Pseudo cognitive training
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Behavior Rating Inventory of Executive Function (BRIEF-A)(Baseline, at 6 weeks, at 12 weeks)
- Change from baseline the parameters of structured cognitive training (CogniPlus®)(Baseline, at 6 weeks, at 12 weeks)
- Change from baseline the composite cognitive functions(Baseline, at 6 weeks, at 12 weeks)
- Change from baseline of the results to task on a driving simulator(Baseline, at 6 weeks, at 12 weeks)
- Number of undesirable effects of treatment(at 2 weeks, at 4 weeks, at 6 weeks, at 12 weeks)
- Hospital Anxiety and Depression scale (HAD)(Baseline, at 6 weeks, at 12 weeks)
- resting state functional MRI(Baseline, at 6 weeks, at 12 weeks)
- Resting state EEG(Baseline, at 6 weeks, at 12 weeks)