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

Mild Cognitive Impairment Clinical Trial

Official title:

Can Methylphenidate (Ritalin) Improve Memory and Attention in Mild Cognitive Impairment? A Combined Behaviour-EEG Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02326038
• Other study ID #: 14T111
• Secondary ID: 2014-003117-28
• Status: Recruiting
• Phase: Phase 4
• First received: December 22, 2014
• Last updated: December 24, 2014
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2014
• Source: Maastricht University Medical Center
• Contact: Anke Sambeth, Dr.
• Phone: 0031 43 3881757
• Email: anke.sambeth[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

• The volunteer is healthy, i.e. absence of all exclusion criteria and has normal static binocular acuity (corrected or uncorrected) as well as normal hearing (using a whisper test during medical screening).

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Drug:
• Methylphenidate
single oral administration of 20 mg tablet

Locations

Country	Name	City	State
Netherlands	Orbis Medical Centre	Sittard-Geleen	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Orbis Medical Centre

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Verbal Learning Test Immediate Recall		140 min after drug intake	No
Primary	Verbal Learning Test Delayed Recall		175 min after drug intake	No
Primary	Verbal Learning Test Recognition	Accuracy and reaction time	180 min after drug intake	No
Primary	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	No
Secondary	Performance on visual and auditory N-back test		150 minutes after drug intake	No
Secondary	Performance on a sustained attention to response task (SART)		165 minutes after drug intake	No
Secondary	Performance on a motor task		170 minutes after drug intake	No
Secondary	Amplitude of ERP components during the visual and auditory N-back test		150-165 minutes after drug intake	No
Secondary	Amplitude of ERP components during SART		165 - 170 minutes after drug intake	No