Mild Cognitive ImpairmentPhase 4NCT02326038
Ritalin, Memory and Attention in MCI: a Behaviour-EEG Study
A Phase 4 study testing Methylphenidate in people with Mild Cognitive Impairment, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Methylphenidate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2014to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Orbis Medical Centre
Sittard-Geleen, Limburg, 6162BG
Walther Sipers, M.D., 0031 884597783, w.sipers@orbisconcern.nl
About this study
Official title: Can Methylphenidate (Ritalin) Improve Memory and Attention in Mild Cognitive Impairment? A Combined Behaviour-EEG Study
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
- Being tested
- Methylphenidate
- Keywords
- Memory, Attention, MCI, Ritalin
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Also called Ritalin
single oral administration of 20 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Ritalin | Experimental | Methylphenidate, capsule, 20 mg, single oral administration Receives: Drug: Methylphenidate |
| Placebo | Placebo comparator | Placebo, capsule, single oral administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Learning Test Immediate Recall
Measured: 140 min after drug intake
Verbal Learning Test Delayed Recall
Measured: 175 min after drug intake
Verbal Learning Test Recognition
Accuracy and reaction time
Measured: 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
Measured: 140-190 min after drug intake
Secondary outcomes (5)
Performance on visual and auditory N-back test
Measured: 150 minutes after drug intake
Performance on a sustained attention to response task (SART)
Measured: 165 minutes after drug intake
Performance on a motor task
Measured: 170 minutes after drug intake
Amplitude of ERP components during the visual and auditory N-back test
Measured: 150-165 minutes after drug intake
Amplitude of ERP components during SART
Measured: 165 - 170 minutes after drug intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Orbis Medical Centre
- Responsible party
- Sponsor
- Investigators
- Anke Sambeth, Dr., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326038
- Sponsor's protocol ID
- 14T111
- Other IDs
- 2014-003117-28, 2014
- Status last verified
- Dec 2014
- First submitted
- 22 Dec 2014
- Last updated
- 25 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Methylphenidate (Ritalin) Improve Memory and Attention in Mild Cognitive Impairment? A Combined Behaviour-EEG Study
- ClinicalTrials.gov ID
- NCT02326038
- Acronym / sponsor ID
- 14T111
- Conditions
- Mild Cognitive Impairment
- Keywords
- Memory, Attention, MCI, Ritalin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Orbis Medical Centre
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ritalin | Experimental | Drug: MethylphenidateMethylphenidate, capsule, 20 mg, single oral administration |
| Placebo | Placebo comparator | –Placebo, capsule, single oral administration |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylphenidateAlso: Ritalinsingle oral administration of 20 mg tablet | Drug | Ritalin |
Primary outcome
Verbal Learning Test Immediate Recall
Time frame: 140 min after drug intake
Verbal Learning Test Delayed Recall
Time frame: 175 min after drug intake
Verbal Learning Test Recognition
Time frame: 180 min after drug intake
Accuracy and reaction time
Amplitude of the N400 and P600 event-related potential (ERP) components
Time frame: 140-190 min after drug intake
during encoding and recognition of words of VLT, measured with EEG
5 secondary outcomes
Performance on visual and auditory N-back test
Time frame: 150 minutes after drug intake
Performance on a sustained attention to response task (SART)
Time frame: 165 minutes after drug intake
Performance on a motor task
Time frame: 170 minutes after drug intake
Amplitude of ERP components during the visual and auditory N-back test
Time frame: 150-165 minutes after drug intake
Amplitude of ERP components during SART
Time frame: 165 - 170 minutes after drug intake
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anke Sambeth, Dr. principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylphenidate in people with Mild Cognitive Impairment, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anke Sambeth, Dr. (0031 43 3881757, anke.sambeth@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal Learning Test Immediate Recall (time frame: 140 min after drug intake). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Dec 2014.