Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT01740960
Eligibility Criteria:
Inclusion Criteria:
* Subject is a healthy old person as established by medical history, physical examination, electrocardiography, results of hematological and biochemical blood tests on screening.
* Age 65 years
* Body mass index between 18.0 and 30 kg m-2
* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
Exclusion Criteria:
* Regular cannabis user, defined as: smoking one or more joints per week
* Documented history of sensitivity/idiosyncrasy to cannabis
* Relevant history or presence of severe pulmonary disorders \[e.g. COPD GOLD III or IV\], serious cardiovascular disorders \[e.g. myocardial infarction \< 6 months ago; atrial fibrillation; heart failure NYHA III or IV; severe heart valve disease, orthostatic hypotension defined as systolic drop of 20 mm Hg Safety and Tolerability of Namisol in the Elderly Page 8 Version 2, 10 07 2012 or diastolic drop of 10 mm Hg\], seizures, migraine, psychiatric disorders \[e.g. depression (based on documented history or GDS-30 on screening ≥ 10); mania; psychosis; dementia\], cognitive impairment \[based on documented history or MMSE on screening \< 28, significant renal (GFR \< 30 ml/min) or hepatic disorders \[e.g. cancer, cirrhosis. ALT or AST ≥ twice the upper limit of normal\], diabetes mellitus, coagulation disorders
* Inability to understand the nature and extent of the trial and the procedures required
* Current alcohol abuse or use of more than 2 alcoholic consumptions daily
* History of, or current drug abuse
* Using drugs that are inhibitors of CYP2C9, CYP2C19 and CYP3A4 (see appendix 13.3)
* Participation in a drug trial within 60 days prior to the first intervention day
* Donation of blood within 60 days prior to the first intervention day
* Known lactose intolerance
* Using more than six units of (methyl)xanthine products per day (e.g. coffee, tea, cola, chocolate)
* Smoking more than ten cigarettes per day
* High fall-risk (based on body sway test)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT01740960
Study Brief:
Protocol Section:
NCT01740960