Efficacy and Safety of MNI-672 SPECT for Detection/Exclusion of Cerebral B-amyloid in AD Subjects Compared to HVs.

Completed · Phase 1

Conditions studied: Alzheimer's Disease

In brief

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

Key facts

Study ID
NCT01859767
Run by
Molecular NeuroImaging
People needed
6
Starts
2013-04-01
Expected to finish
2015-04-01
Last updated by the study team
2016-12-16

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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