Efficacy and Safety of MNI-672 SPECT for Detection/Exclusion of Cerebral B-amyloid in AD Subjects Compared to HVs.
Status:
Completed
Trial end date:
2015-04-01
Target enrollment:
Participant gender:
Summary
This is a Phase 1, single center, open-label, non-randomized, clinical study in probable AD
patients and HVs to evaluate the efficacy, safety and tolerability of a single dose of
MNI-672. The underlying goal of this study is to assess MNI-672 SPECT imaging as a tool to
detect ß amyloid deposition in the brain of AD research participants and young healthy male
subjects. All study procedures will be conducted at Molecular NeuroImaging (MNI) in New
Haven, CT. Approximately 3 patients with AD and 3 young male HVs will be recruited to
participate in this study. HVs will be screened to ensure that there is no evidence of
cognitive decline or significant neurological deficit.
All eligible subjects will be required to visit the study center on at least 2 occasions:
1. for one or more screening visits which should include a history and physical
examination, laboratory and extensive neuro-psychological testing and MRI brain
scanning. AD subjects will also undergo Amyvid PET imaging as part of the Screening
Visit.
2. on one day for baseline examinations and MNI-672 administration and subsequent SPECT
scanning- followed by safety measures