Hôpital Roger Salengro, CHU
Lille, France
NCT Number: NCT03280251
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.
Looking for future studies?
Notify Me55 year–75 year
All sexes
Interventional
Phase 2
Lille, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 6 weeks after the beginning of the treatment
Time frame: Baseline, at 6 weeks, at 12 weeks
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
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
Time frame: Baseline, at 6 weeks, at 12 weeks
Time frame: at 2 weeks, at 4 weeks, at 6 weeks, at 12 weeks
Time frame: Baseline, at 6 weeks, at 12 weeks
A composite measure of parameters following : processing speed, inhibition and working memory resources.
Time frame: Baseline, at 6 weeks, at 12 weeks
EEG with Attentional Network Test and Go / No Go task
Time frame: Baseline, at 6 weeks, at 12 weeks
The changes of resting state functional MRI after treatment and cognitive training
University Hospital, Lille
Other
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
Acronym: PACTE-1
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