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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21957
Enrollment
120
Registered
2017-04-19
Start date
2017-06-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long-term memory

Interventions

Volunteers 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 ra

Sponsors

Maastricht University, Department of Neuropsychology & Psychopharmacology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. 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)

Design outcomes

Primary

MeasureTime frame
To 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

MeasureTime frame
Performance 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.

Contacts

Public ContactAnke Sambeth

Faculty of Psychology Dept. of Neuropsychology and Psychopharmacology PO Box 616

anke.sambeth@psychology.unimaas.nl0031-(0)43-3881757

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)