NCT01859767

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

An Exploratory, Open-label, Non-randomized Phase 1 Study to Evaluate the Efficacy and Safety of MNI-672 SPECT for Detection/Exclusion of Cerebral B-amyloid in Patients With Alzheimer's Disease Compared to Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Molecular NeuroImaging · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

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

Detailed description

To determine diagnostic efficacy of the MNI-672 SPECT scans in differentiating between patients with probable AD and HVs on the basis of neocortical tracer binding pattern, the SPECT scans will be visually assessed by a nuclear physician experienced in the field of neuro-imaging. SPECT scan findings will be classified either as abnormal (i.e., significant neocortical uptake in predefined regions) or as normal (i.e. no significant neocortical uptake in predefined regions). The visual analysis of the MNI SPECT images will be compared to the clinical diagnosis and Amyvid PET imaging results to determine the efficacy of MNI-672 as an agent to detect B-amyloid. The nuclear physician evaluating the SPECT images will be unaware of the clinical diagnosis.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	[123I]MNI-672 SPECT	Subjects will be dosed by intravenous injection to a target dose of 5 mCi and not to exceed 5.5 (not \>10% of 5 mCi limit) I-123 MNI-672 prior to the SPECT scan.

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-03-01
• Completion: 2015-04-01
• First posted: 2013-05-22
• Last updated: 2016-12-16

Locations

1 site across 1 country: United States