Back to results

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

Primary Purpose

Mild Cognitive Impairment

Status

Unknown status

Phase

Phase 4

Locations

Netherlands

Study Type

Interventional

Intervention

Methylphenidate

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Memory, Attention, MCI, Ritalin

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Orbis Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ritalin

Placebo

Arm Description

Methylphenidate, capsule, 20 mg, single oral administration

Placebo, capsule, single oral administration

Outcomes

Primary Outcome Measures

Verbal Learning Test Immediate Recall

Verbal Learning Test Delayed Recall

Verbal Learning Test Recognition

Accuracy and reaction time

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

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

Secondary Outcome Measures

Performance on visual and auditory N-back test

Performance on a sustained attention to response task (SART)

Performance on a motor task

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

Amplitude of ERP components during SART

Full Information

NCT ID

NCT02326038

First Posted

December 22, 2014

Last Updated

December 24, 2014

Sponsor

Maastricht University Medical Center

Collaborators

Orbis Medical Centre

1. Study Identification

Unique Protocol Identification Number

NCT02326038

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Unknown status

Study Start Date

November 2014 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maastricht University Medical Center

Collaborators

Orbis Medical Centre

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment

Keywords

Memory, Attention, MCI, Ritalin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ritalin

Arm Type

Experimental

Arm Description

Methylphenidate, capsule, 20 mg, single oral administration

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo, capsule, single oral administration

Intervention Type

Drug

Intervention Name(s)

Methylphenidate

Other Intervention Name(s)

Ritalin

Intervention Description

single oral administration of 20 mg tablet

Primary Outcome Measure Information:

Title

Verbal Learning Test Immediate Recall

Time Frame

140 min after drug intake

Title

Verbal Learning Test Delayed Recall

Time Frame

175 min after drug intake

Title

Verbal Learning Test Recognition

Description

Accuracy and reaction time

Time Frame

180 min after drug intake

Title

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

Description

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

Time Frame

140-190 min after drug intake

Secondary Outcome Measure Information:

Title

Performance on visual and auditory N-back test

Time Frame

150 minutes after drug intake

Title

Performance on a sustained attention to response task (SART)

Time Frame

165 minutes after drug intake

Title

Performance on a motor task

Time Frame

170 minutes after drug intake

Title

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

Time Frame

150-165 minutes after drug intake

Title

Amplitude of ERP components during SART

Time Frame

165 - 170 minutes after drug intake

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anke Sambeth, Dr.

Phone

0031 43 3881757

anke.sambeth@maastrichtuniversity.nl

First Name & Middle Initial & Last Name or Official Title & Degree

Walther Sipers, M.D.

Phone

0031 88 4597783

w.sipers@orbisconcern.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anke Sambeth, Dr.

Organizational Affiliation

Maastricht University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Orbis Medical Centre

City

Sittard-Geleen

State/Province

Limburg

ZIP/Postal Code

6162BG

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Walther Sipers, M.D.

Phone

0031 884597783

w.sipers@orbisconcern.nl

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs