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 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT02874820
Eligibility Criteria:
Inclusion Criteria:
* Male aged 50 to 80 years
* Subjects who meet the NIA-AA core clinical criteria for probable Alzheimer's disease dementia
* Clinical Dementia Rating (CDR) score of 0.5 or more and MMSE ≥ 17
* Subjects on acetylcholinesterase inhibitor or memantine therapy for Alzheimer's disease must be on a stable dose prior to baseline
* Subjects must have partners/caregivers able to accompany them during the study visits, as well as monitor for, and report, any adverse events to the study team in the week after scanning
* Non-smoker
* Willing to comply with protocol and lifestyle restrictions
* Excellent understanding of English (for questionnaires)
* Participant is ambulant and capable of attending a PET scan visit as an outpatient.
* Participants with female partners of child-bearing potential must agree to use one of the contraception methods listed in Section 7.5.1. This criterion must be followed from after the first PET Scan until after the follow-up contact.
* Adequate collateral flow to the radial and ulnar arteries in both hands as determined by an Allen's test.
* Body weight ≥50 kg.
Exclusion Criteria:
* Current or past history of major psychiatric disorder
* Current or past history of substance use disorder
* Clinically significant brain injury or abnormality
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* History of or suffers from claustrophobia or subject feels unable to lie flat and still on their back for a period of up to 2 hours in the PET/CT scanner.
* Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations or occupational exposure resulting in radiation exposure greater than 10 mSv over the past 3 years or greater than 10 mSv in a single year including the proposed study. Clinical exposure from which the subject receives a direct benefit is not included in these calculations.
* Previous inclusion in a research and/or medical protocol involving study medication within the last 3 months
* In the opinion of the study team they are unlikely to comply with the study protocol and restrictions that it imposes.
* Contraindications for subjects undergoing an MR scan (including but not limited to metal implants pacemakers, etc.)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT02874820
Study Brief:
Protocol Section:
NCT02874820