drugset / Trial / NCT03280251

Methylphenidate and Cognitive Training in Elderly

NCT03280251

Phase 2 Completed 31 enrolled University Hospital, Lille
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2018-09-19
Primary completion
2020-03-11
Completion
2020-03-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylphenidate Small molecule 0.3 mg/kg

Indications

No indication recorded.