NCT02928211

Aftobetin-HCl and Fluorescence Detection Measured by Sapphire II to Determine the Number and Timing of Administrations

An Evaluation of Aftobetin-HCl and Fluorescence Detection as Measured by Sapphire II to Determine the Number and Timing of Administrations in Subjects With Normal Cognition, Mild Cognitive Impairment, and Mild Alzheimer's Disease

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Cognoptix, Inc. · Industry
• Sex: All
• Age: 25 Years – 90 Years
• Healthy volunteers: Accepted

Summary

This is an open-label study to evaluate Aftobetin-HCl and florescence detection as measured by the Sapphire II device. Performance of Part I of the study has been completed (15 subjects received a single administration of Aftobetin HCL followed by Sapphire II measurements) and indicated that 3 administrations of Aftobetin-HCl are necessary. For Part II, a second group of up to 30 subjects (CN =10 and mild AD or MCI =20) will receive three Aftobetin HCL administrations. If three administrations of Aftobetin HCL are optimal, up to an additional 30 MCI and 30 mild AD subjects will be entered. The purpose of the study as Part II is performed is to determine the ability of the Sapphire II device to detect B-amyloid in the lens of the eye in subjects with Mild Cognitive Impairment (MCI), and mild Alzheimer's Disease (AD) after three Aftobetin-HCl administrations. Subjects with Normal Cognition (CN) will also be tested to further establish that subjects who are highly unlikely to have B-amyloid deposits in the lens of the eye will have close to baseline post ligand fluorescent uptake value (FUV) using the Sapphire II technology.

Detailed description

Open label study. 45-105 subjects will be enrolled. Subjects will undergo the following procedures: * Complete physical and neurologic examination (Screening) * Neuropsychological testing (Screening) * Ophthalmologic examination (Screening and Visit 4 (Safety follow up visit)) * Administration of ointment - 3 administrations (Visit 1) * Sapphire II Fluorescent Eye Measurements (Visits 1-3): Prior to first administration of ointment and then 24 +/- 2 hours, 28 +/- 30 minutes and 48 +/- 2 hours following first ointment administration * Amyvid Positron Emission Tomography (PET) Amyloid Scan (only required for MCI and mild AD subjects who have not had a positive amyloid PET scan in the last 3 years) Subjects will also be asked to participate in an elective second Sapphire II assessment to assess its reproducibility. Repeatability testing is optional and will require a separate consent. Subjects will come back for Visits 5-9 (ointment administration and eye scans and a follow up safety assessment).

Conditions

• Mild Cognitive Impairment
• Alzheimer's Disease

Interventions

Type	Name	Description
DEVICE	Sapphire II	A Class 1 laser device used in conjunction with the ointment to measure fluorescence emissions from the anterior segment (lens) of the eye.
DRUG	Aftobetin-HCl	The medical imaging agent (the ointment), Aftobetin-HCl is an amyloid binding ligand formulated into an ophthalmic ointment.
RADIATION	Positron Emission Tomography	Amyvid 370 MBq (10 mCi) is administered as a single bolus through a short intravenous catheter in a total volume of 10 mL.

Timeline

• Start date: 2016-07-01
• Primary completion: 2018-12-01
• Completion: 2019-01-01
• First posted: 2016-10-10
• Last updated: 2018-08-22

Locations

1 site across 1 country: United States