NCT03280251

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Methylphenidate	Methylphenidate (capsules of Ritaline LP 10) encapsulated, 0,3 mg per kg per day during 6 weeks
DRUG	Placebo	Placebo, identical capsules to encapsulated MPH, number of capsules per day identical to MPH during 6 weeks
OTHER	CogniPlus software	Structured cognitive training with CogniPlus software, twice per week during 6 weeks
OTHER	Pseudo cognitive training	Pseudo cognitive training with 45 minutes documentary videos and 15 minutes quiz, twice per week during 6 weeks

Timeline

• Start date: 2018-09-19
• Primary completion: 2020-03-11
• Completion: 2020-03-11
• First posted: 2017-09-12
• Last updated: 2025-12-11

Locations

1 site across 1 country: France