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The effects of a cognition enhancer (CILTEP) on a cognitive test battery and EEG in middle-aged and old volunteers


- candidate number27111
- NTR NumberNTR6400
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-apr-2017
- Secondary IDsNL60999.068.17 METC 173009
- Public TitleThe effects of a cognition enhancer (CILTEP) on a cognitive test battery and EEG in middle-aged and old volunteers
- Scientific TitleThe effects of a cognition enhancer (CILTEP) on a cognitive test battery and EEG in middle-aged and old volunteers
- ACRONYMCILTEP and cognition
- hypothesis- CILTEP can improve cognition in healthy volunteers, specifically memory
- The effects of CILTEP will be discernable in the ERP components measured: the P50, P300, N400, and P600 amplitudes are expected to be enlarged by CILTEP
- Healt Condition(s) or Problem(s) studiedLong term results
- Inclusion criteria1. Male or female;
2. 30 to 40 or 60 to 75 years of age;
3. healthy (i.e. absence of all exclusion criteria);
4. body mass index between 18.5 and 30;
5. Verbal Learning Test screening score within the -1 and +1 standard deviation;
6. willingness to sign an informed consent.
- Exclusion criteria1. history of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, haematological, or psychiatric ilness or a first-degree relative with a psychiatric disorder or a history with a psychiatric disorder;
2. excessive drinking (> 20 glasses of alcohol containing beverages a week);
3. pregnancy or lactation;
4. use of use of psychoactive medication or centrally acting beta blockers;
5. use of recreational drugs from 2 weeks before the experiment until the end of the study;
6. systolic blood pressure above 160 mmHg;
7. phenylketonuria;
8. any sensory or motor deficits which could reasonably be expected to affect test performance;
9. use of steroids or Sudafed (pseudoephedrine)
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2017
- planned closingdate31-aug-2017
- Target number of participants120
- InterventionsVolunteers will be tested on 2 separate days and will be administered either CILTEP or a placebo. Before inclusion, they will undergo a memory and a medical screening The order of treatment will be randomized.
- Primary outcomeTo establish the effects of CILTEP on cognition, especially memory. The main cognitive tests that will be used are the verbal learning task (VLT), in which participants need to memorize words that are presented on a screen, and the spatial pattern separation test, using photographs to assess episodic memory.
- Secondary outcomePerformance in several other cognitive tests will be our secondary objective. We will examine the effects of CILTEP on working memory performance using an n-back task, on information processing speed using the digit symbol substitution test (DSST), on motor speed using a simple and choice reaction time task (SRT and CRT, respectively), on attention and concept shifting using the trail making test, and on response inhibition and focused attention using the Stroop. A sensory gating paradigm is included to examine the effect of our treatment on specific ERP components related to basic auditory processing.
- TimepointsN/A
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Anke Sambeth
- CONTACT for SCIENTIFIC QUERIES Anke Sambeth
- Sponsor/Initiator Maastricht University, Department of Neuropsychology & Psychopharmacology
- Funding
(Source(s) of Monetary or Material Support)
Natural Stacks
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD19-apr-2017 - 21-jun-2017


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