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 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT02593318
Eligibility Criteria:
Inclusion Criteria:
* Have a diagnosis of probable Alzheimer's disease (AD) per McKhann et al. criteria \[9\];
* Have a clinical dementia rating (CDR) score of 0.5 or 1 at time of their last University of Kansas Alzheimer's Disease Center (KU ADC) assessment;
* Have a Mini Mental Status Exam (MMSE) score of 15-28 at the TOAD screening visit;
* Have a reliable and competent study partner who is willing to accompany the participant to all study visits, monitor compliance of study medication administration, and observe/report any changes in the participant's health throughout the study duration;
* Are on stable doses of concurrent medications for at least 4 weeks prior to the TOAD screening visit; and
* Speaks English as his/her primary language.
* If female of child-bearing potential, must have a negative urine pregnancy test at TOAD screening visit (and must agree to use of contraception throughout the trial)
Exclusion Criteria:
* Dementia due to causes other than AD;
* Potentially confounding, serious, or unstable medical conditions such as:
* insulin-dependent diabetes mellitus
* cancer within the past 3 years (except basal cell, squamous cell, or localized prostate cancer)
* a recent cardiac event (i.e. heart attack, angioplasty, etc. within the 6 months prior to screening visit)
* other conditions that pose a potential safety risk or confounding factor in the investigator's opinion;
* Any abnormal physical examination assessment or vital sign assessment at TOAD screening visit that is deemed to be clinically significant by the principal investigator;
* Any abnormal clinical laboratory test result at TOAD screening visit that is deemed to be clinically significant by the principal investigator.
* Any contraindication for undergoing magnetic resonance spectroscopy (MRS), such as the presence of metal implants, a cardiac pacemaker that is not compatible with MRS, or severe claustrophobia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT02593318
Study Brief:
Protocol Section:
NCT02593318