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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
31
Methylphenidate (capsules of Ritaline LP 10) encapsulated, 0,3 mg per kg per day during 6 weeks
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
Pseudo cognitive training with 45 minutes documentary videos and 15 minutes quiz, twice per week during 6 weeks
Hôpital Roger Salengro, CHU
Lille, France
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
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
Time frame: 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.
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®)
A composite measure of parameters following : processing speed, inhibition and working memory resources.
Time frame: Baseline, at 6 weeks, at 12 weeks
Resting state EEG
EEG with Attentional Network Test and Go / No Go task
Time frame: Baseline, at 6 weeks, at 12 weeks
resting state functional MRI
The changes of resting state functional MRI after treatment and cognitive training
Time frame: Baseline, at 6 weeks, at 12 weeks
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