Ritalin, Memory and Attention in MCI: a Behaviour-EEG Study

NCT02326038 | Unknown Phase 4

• 2 other identifiers: 14T1112014-003117-28
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Traditionally, memory impairments in the elderly population are treated using cholinesterase inhibitors, although impairments remain after treatment. Dopamine (DA) is also involved in cognition and is especially of interest in healthy ageing because of the role in processing speed and cognitive control. To what extent dopamine treatment improves memory and attention in older impaired individuals is unknown. However, such an effect is conceivable because of the close relationship between memory and attention in aging and since improved processing speed and cognitive control may lead to improved memory. The investigators aim to examine, in the impaired older population, whether a treatment using methylphenidate, a DA re-uptake inhibitor that enhances DA, improves attention and memory. The study will be conducted according to a cross-sectional, double-blind, placebo-controlled, 2-way cross-over design. 20 male and female patients with Mild Cognitive Impairment (MCI), amnestic type, aged above 60 years of age; 20 male and female patients with MCI, non-amnestic type, will be recruited from the Orbis Medical Centre. Participants will be treated once with 20 mg methylphenidate (MPH) and once with placebo. All medications will be administered orally with a capsule. The treatment order will be established by counterbalancing.

Conditions

Mild Cognitive Impairment

Keywords

Memory; Attention; MCI; Ritalin

Outcome Measures

Primary Outcomes (4)

• Verbal Learning Test Immediate Recall

  140 min after drug intake

• Verbal Learning Test Delayed Recall

  175 min after drug intake

• Verbal Learning Test Recognition

  Accuracy and reaction time

  180 min after drug intake

• Amplitude of the N400 and P600 event-related potential (ERP) components

  during encoding and recognition of words of VLT, measured with EEG

  140-190 min after drug intake

Secondary Outcomes (5)

• Performance on visual and auditory N-back test

  150 minutes after drug intake

• Performance on a sustained attention to response task (SART)

  165 minutes after drug intake

• Performance on a motor task

  170 minutes after drug intake

• Amplitude of ERP components during the visual and auditory N-back test

  150-165 minutes after drug intake

• Amplitude of ERP components during SART

  165 - 170 minutes after drug intake

Study Arms (2)

Ritalin

EXPERIMENTAL

Methylphenidate, capsule, 20 mg, single oral administration

Drug: Methylphenidate

Placebo

PLACEBO COMPARATOR

Placebo, capsule, single oral administration

Interventions

Methylphenidate DRUG

single oral administration of 20 mg tablet

Also known as: Ritalin

Ritalin

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant has been diagnosed with Mild Cognitive Impairment, either of the amnestic or the non-amnestic type.
• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
• The participant signs and dates a written informed consent form.
• The volunteer is male or female.
• The participant is aged 60 to 80 years, inclusive, at the time of informed consent.
• The participant has a body mass index of 18.5-30, inclusive, at medical screening.

You may not qualify if:

• The subject has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality which may impact the ability of the subject to participate or potentially confound the study results.
• The volunteer has uncontrolled existing major psychiatric symptoms.
• The subject has uncontrolled hypertension.
• The volunteer has hyperthyroidism.
• The participant has known hypersensitivity to any component of the formulation of MPH or related compounds.
• The participant has glaucoma.
• The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the first visit or is unwilling to agree to abstrain from alcohol from 24 hours prior to each test day and/or drugs throughout the study.
• The participant has any sensory or motor deficits which could reasonably be expected to affect test performance.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Orbis Medical Centre: collaborator

Study Sites (1)

Orbis Medical Centre

Sittard-Geleen, Limburg, 6162BG, Netherlands

RECRUITING

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

• Anke Sambeth, Dr.

  Maastricht University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anke Sambeth, Dr.

CONTACT

0031 43 3881757; anke.sambeth@maastrichtuniversity.nl

Walther Sipers, M.D.

CONTACT

0031 88 4597783; w.sipers@orbisconcern.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: December 25, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 25, 2014

Record last verified: 2014-12

Locations

NL (1)