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

Phase 1

Completed

• Conditions: Healthy Volunteers; Parkinson Disease; Alzheimer Disease
• Interventions: Drug: [18F]MNI-1126

• Registration Number: NCT03587649
• Lead Sponsor: Invicro

Brief 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.

Study Timeline

• Study Start: 2018-05-07
• Study First Submitted: 2018-07-03
• Study First Submitted QC: 2018-07-03
• Study First Posted: 2018-07-16
• Primary Completion: 2020-02-26
• Study Completion: 2020-02-26
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-13
• Last Update Posted: 2020-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[18F]MNI-1126	[18F]MNI-1126	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.

Primary Outcome Measures

Name	Time	Method
Regions in the VOI template will be used to quantify the regional tracer uptake and used for comparison of potential uptake differences across the different groups.	1 year	Descriptive statistics will be applied to describe the tau deposition by region as measured by \[18F\]MNI-1126.

Trial Locations

Locations (1)

Invicro; 🇺🇸 New Haven, Connecticut, United States