MedTrace Logo

Methylphenidate and Cognitive Training in Elderly

NCT03280251 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-12-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • David Devos, MD,PhD · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03280251 on ClinicalTrials.gov