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

NCT01859767 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2016-12-16

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Molecular NeuroImaging

    lead OTHER

Principal Investigators

  • Danna Jennings, MD · Molecular NeuroImaging, LLC

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-03-31
Completion
2015-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01859767 on ClinicalTrials.gov