NCT03587649

Evaluation of [18F]MNI-1126 as an Imaging Marker for Synaptic Density Loss

Evaluation of [18F]MNI-1126 as an Imaging Marker for Synaptic Density Loss in the Brain of Patients With Probable Alzheimer's Disease, Probable Parkinson's Disease (PD) Subjects as Compared to Healthy Volunteers (HV).

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Invicro · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this protocol is to examine \[18F\]MNI-1126 as a tool to assess synaptic density loss.

Detailed description

The primary objective of this protocol is to examine \[18F\]MNI-1126 as a tool to assess synaptic density loss.The specific objectives are: * Examine \[18F\]MNI-1126 as a tool to assess synaptic density loss. * To measure the dynamic uptake and washout of \[18F\]MNI-1126 in the brain using positron emission tomography (PET) in subjects with AD, PD, and healthy volunteers. * To measure blood metabolites of \[18F\]MNI-1126 and perform kinetic modeling to assess its ability to measure synaptic density loss in the brain using the tracer plasma concentration or a reference region as indirect input. * To acquire safety data following injection of \[18F\]MNI-1126.

Conditions

• Alzheimer Disease
• Parkinson Disease
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	[18F]MNI-1126	Florbetapir PET imaging will be completed in all healthy volunteers and AD subjects as part of the screening procedures. DaTscan SPECT imaging will be completed in those PDsubjects who have not previously had DaTscan imaging as part of the screening procedures.

Timeline

• Start date: 2018-05-07
• Primary completion: 2020-02-26
• Completion: 2020-02-26
• First posted: 2018-07-16
• Last updated: 2020-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study