Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02874820 : I2PETPG - Imidazoline2 Binding Sites in a Group of Participants Diagnosed With AD
PhasePhase 0
AgesMin: 50 Years Max: 80 Years
Eligibility
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.)
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02874820      |      Link to official Clinicaltrials.gov listing
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