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:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT02679235
Eligibility Criteria:
Inclusion Criteria:
* Men and women ≥65 years old;
* Score ≥26/30 on the Montreal Cognitive Assessment; -≥10% lower brain glucose uptake in the frontal cortex as determined by PET imaging.
Exclusion Criteria:
* Score \<26/30 on the Montreal Cognitive Assessment;
* Medications likely to affect the primary cognitive outcome;
* Medical or psychiatric conditions that could interfere with study participation (Peterson et al. 2005);
* Fasting plasma glucose ≥7.0 mM (to avoid recruiting diabetics or pre-diabetics, both of which are risk factors for cognitive impairment in older persons (Mortimer et al. 2010) and also inhibit ketogenesis (Fukao et al. 2004);
* Clinically-significant gastro-intestinal disease/conditions;
* Clinically-significant liver disease/dysfunction : ALT ≥37 UI/L, AST ≥36 UI/L, Total bilirubin ≥26 μmol/L;
* Clinically-significant renal disease/dysfunction : creatinine ≥92 μmol/L, glomerular filtration rate \<60 ml/min/1.73 m2 or \>90 ml/min/1.73 m2;
* Clinically-significant cardiac disease/conditions;
* Clinically-significant abnormal coagulation laboratory results or coagulation disorders at screening;
* Poorly controlled dyslipidemia (total cholesterol ≥6.2 mmol/L or triglycerides ≥2.20 mmol/L)
* Hypertension: ≥140/90 mmHg;
* Substance abuse;
* Already on MCT supplementation;
* Visual or hearing impairment impeding comprehension;
* Non-French speaking;
* Any condition with life expectancy less than 5 years;
* Institutionalized or intending to move out of area within 1 year;
* Participation in other intervention trials.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT02679235
Study Brief:
Protocol Section:
NCT02679235