Methylphenidate and Cognitive Training in Elderly

NCT03280251 | Completed Phase 2 DMC

• 2 other identifiers: 2015_812016-005131-32
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cognitive disorders; cognitive training; symptomatic treatment; Methylphenidate; elderly

Outcome Measures

Primary Outcomes (1)

• The difference of the average response time to a choice task at inclusion and at the end of treatment (after 6 weeks)

  6 weeks after the beginning of the treatment

Secondary Outcomes (8)

• Change from baseline the composite cognitive functions

  Baseline, at 6 weeks, at 12 weeks

• Change from baseline of the results to task on a driving simulator

  Baseline, at 6 weeks, at 12 weeks

• Behavior Rating Inventory of Executive Function (BRIEF-A)

  Baseline, at 6 weeks, at 12 weeks

• Hospital Anxiety and Depression scale (HAD)

  Baseline, at 6 weeks, at 12 weeks

• Number of undesirable effects of treatment

  at 2 weeks, at 4 weeks, at 6 weeks, at 12 weeks

Study Arms (4)

Methylphenidate and structured cognitive training

EXPERIMENTAL

Methylphenidate (capsules of Ritaline LP 10) encapsulated, 0,3 mg per kg per day during 6 weeks Structured cognitive training with CogniPlus software, twice per week during 6 weeks

Drug: Methylphenidate; Other: CogniPlus software

Placebo and structured cognitive training

EXPERIMENTAL

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

Drug: Placebo; Other: CogniPlus software

Methylphenidate and pseudo cognitive training

EXPERIMENTAL

Methylphenidate (capsules of Ritaline LP 10) encapsulated, 0,3 mg per kg per day during 6 weeks Pseudo cognitive training with 45 minutes documentary videos and 15 minutes quiz, twice per week during 6 weeks

Drug: Methylphenidate; Other: Pseudo cognitive training

Placebo and pseudo cognitive training

EXPERIMENTAL

Placebo, identical capsules to encapsulated MPH, number of capsules per day identical to MPH during 6 weeks Pseudo cognitive training with 45 minutes documentary videos and 15 minutes quiz, twice per week during 6 weeks

Drug: Placebo; Other: Pseudo cognitive training

Interventions

Methylphenidate DRUG

Methylphenidate (capsules of Ritaline LP 10) encapsulated, 0,3 mg per kg per day during 6 weeks

Methylphenidate and pseudo cognitive training; Methylphenidate and structured cognitive training

Placebo DRUG

Placebo, identical capsules to encapsulated MPH, number of capsules per day identical to MPH during 6 weeks

Placebo and pseudo cognitive training; Placebo and structured cognitive training

CogniPlus software OTHER

Structured cognitive training with CogniPlus software, twice per week during 6 weeks

Methylphenidate and structured cognitive training; Placebo and structured cognitive training

Pseudo cognitive training OTHER

Pseudo cognitive training with 45 minutes documentary videos and 15 minutes quiz, twice per week during 6 weeks

Methylphenidate and pseudo cognitive training; Placebo and pseudo cognitive training

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Without severe chronic neurological or mental or psychiatric pathology
• Absence of cognitive impairment affecting autonomy (scores on the dementia scale of Mattis\> 130 and the IADL = 4)
• Right-handed participant
• Subjects holding driving license B and continuing a driving activity
• Affiliate or beneficiary of a social security scheme
• Subject having signed informed consent
• Subject having agreed to be registered on the National File of Healthy Volunteers
• Patient willing to comply with all procedures of the study and its duration
• No planned changes in lifestyle (nutritional and physical, social interactions) during the life of the protocol

You may not qualify if:

• Administrative reasons: impossibility of receiving informed information, inability to participate in the whole study, absence of coverage by the social security system, refusal to sign consent.
• Subject under tutelage or curatelle.
• Subject during breastfeeding or pregnancy.
• Subject not sufficiently fluent in the French language to understand the instructions necessary to carry out the cognitive tests.
• Subject with uncorrected visual pathology or motor pathology (orthopedic example) likely to interfere with the passing of tests.
• Subject with dependencies pre-existing to medicines, drugs or alcohol.
• Presence of contraindications to MRI: Claustrophobia, Anxiety crisis, Morphotype not allowing access to MRI, metal implant (eg a pacemaker), surgical clips Ferromagnetic, orbital or brain metallic foreign bodies).
• Hypersensitivity to methylphenidate or any other constituents of the product.
• Subject with a personal and / or family history of motor tics and Gilles de la Tourette syndrome.
• Subjects with dysthyroidism or thyrotoxicosis
• Subjects with pre-existing cardiovascular disorders including severe hypertension, heart failure, occlusive arterial disease, angina pectoris, congenital heart disease with hemodynamic repercussions, cardiomyopathy, myocardial infarction, arrhythmias and channelopathies
• Subject with angle-closure glaucoma.
• Significant abnormalities on MRI and EEG according to the investigator's judgment
• Presence of untreated hypertension discovered during screening
• Subject with pheochromocytoma

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Roger Salengro, CHU

Lille, France

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• David Devos, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 12, 2017
• Study Start: September 19, 2018
• Primary Completion: March 11, 2020
• Study Completion: March 11, 2020
• Last Updated: December 11, 2025

Record last verified: 2023-11

Locations

FR (1)