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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003117-28 | EudraCT Number |
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| Name | Class |
|---|---|
| Orbis Medical Centre | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ritalin | Experimental | Methylphenidate, capsule, 20 mg, single oral administration |
|
| Placebo | Placebo Comparator | Placebo, capsule, single oral administration |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate | Drug | single oral administration of 20 mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anke Sambeth, Dr. | Contact | 0031 43 3881757 | anke.sambeth@maastrichtuniversity.nl | |
| Walther Sipers, M.D. | Contact | 0031 88 4597783 | w.sipers@orbisconcern.nl |
| Name | Affiliation | Role |
|---|---|---|
| Anke Sambeth, Dr. | Maastricht University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orbis Medical Centre | Recruiting | Sittard-Geleen | Limburg | 6162BG | Netherlands |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| 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 |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |