Aftobetin-HCl and Fluorescence Detection Measured by Sapphire II to Determine the Number and Timing of Administrations
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|ClinicalTrials.gov Identifier: NCT02928211|
Recruitment Status : Recruiting
First Posted : October 10, 2016
Last Update Posted : August 22, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment Alzheimer's Disease||Device: Sapphire II Drug: Aftobetin-HCl Radiation: Positron Emission Tomography||Phase 1|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||105 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||July 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||January 2019|
All subjects will receive the ointment and have scans with the Sapphire II device
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.
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.
Other Name: PET
- Paired pre-ligand and post ligand fluorescent uptake values (FUV) [ Time Frame: through study completion, approximately 4 weeks ]
- Determination of success (yes or no) [ Time Frame: through study completion, approximately 4 weeks ]Determination of success (yes or no) associated with FUVs obtained after one dose or two doses of ligand at each time point by subject
- The overall diagnostic precision for each combination of Aftobetin-HCl administrations and Fluorescent Uptake Value (FUV) [ Time Frame: through study completion, approximately 4 weeks ]
The overall diagnostic precision for each combination of:
- The number of Aftobetin-HCl administrations and
- Fluorescent Uptake Value (FUV): amyloid binding of Aftobetin-HCl to the lens of the eye as measured by Sapphire II system at 1, 2, 3, 4, 5, 6 (+/-10 minutes) and 24 hour (+/- 2 hours) time points for Part I and
- Fluorescent Uptake Value (FUV): amyloid binding of Aftobetin-HCl to the lens of the eye as measured by Sapphire II system at 24 hours (+/-2 hours), 28 hours (+/- 30 minutes) and 48 hours (+/- 2 hours) for Part II.
- Estimates of sensitivity and specificity of MCI and mild AD subjects compared to cognitively normal subjects [ Time Frame: through study completion, approximately 4 weeks ]
- Safety of Sapphire II procedure as determined by instances of Adverse Events [ Time Frame: through the follow up safety visit, approximately 4 weeks ]
- Characterization of maximal fluorescence after 1, or potentially 3, ointment administrations [ Time Frame: through study completion, approximately 4 weeks ]
- Intra-class correlation of the repeatability of the Sapphire II measurements to verify the system's reliability for reproducible results [ Time Frame: through study completion, approximately 6 weeks ]Optional repeatability portion of the study
- Correlation of FUV to PET amyloid status [ Time Frame: through study completion, approximately 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02928211
|Contact: Dennis Nilan||(978) firstname.lastname@example.org|
|United States, Florida|
|Neurology Research Institute||Recruiting|
|West Palm Beach, Florida, United States, 33407|
|Contact: Teresa Villena 561-845-0500 email@example.com|
|Study Director:||Joyce Myers, MD||Cognoptix, Inc.|