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

Status unconfirmed · Phase 1

Conditions studied: Mild Cognitive Impairment, Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT02928211

Run by

Cognoptix, Inc.

People needed

105

Starts

2016-07-01

Expected to finish

2019-01-01

Last updated by the study team

2018-08-22

Who can join

Age: 25 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Serious underlying medical disease which in the opinion of the investigator may interfere with the participant's ability to participate in the study such as unstable cardiac, pulmonary, renal, hepatic, endocrine, hematologic, active malignancy or infectious disease;
• Non-AD causes of dementia that could cause impaired memory ruled out by standardized work up for dementia;
• Significant neurologic disease (e.g., Parkinson's Disease, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis);
• Clinically relevant, abnormal serum chemistry, B12, TSH, and CBC <6 months of study entry;
• History of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities, learning disability or mental retardation;
• Significant psychiatric illness in last year such as major depression, bipolar, obsessive compulsive or psychotic disorder;
• History of alcohol or substance abuse in last year;
• Pain or sleep disorder that could interfere with cognitive testing;
• Known hypersensitivity to Amyvid (Florbetapir-F 18) or any components of injection formulation or contraindication to PET scan (e.g., pregnant, lactating, or of childbearing potential) in subjects requiring a PET scan.
• Receiving any investigational medications or participated in a trial with investigational medications within 30 days prior study entry;
• History of bilateral cataract surgery;
• Active ocular inflammation or infection;
• History of physical injury or other serious eye disease;
• Corneal disease that prevents visualization of the lens, e.g, Fuch's dystrophy or keratokonus;
• Inability to tolerate the PET environment, e.g., due to physical size and/or claustrophobia in subjects requiring a PET scan.
• Serious suicidal ideation in the opinion of the investigator or answers 'yes' to Item 4 or 5 on the Columbia Suicide Severity Rating Scale (CSSRS) at screening;
• Inability to undergo MRI procedure (e.g., metal implant, metallic devices, e.g., non-MRI-safe cardiac pacemaker or neuro-stimulator, some artificial joints, metal pins, surgical clips, other implanted metal, or claustrophobia or discomfort in confined spaces)
• May not be taking any of the following psychoactive medications:
• Regular use narcotic analgesics (>2 doses/ week)
• Clonidine, neuroleptics, antidepressants with central anticholinergic activity
• Other agents with central anticholinergic activity such as diphenhydramine, hydroxyzine, benztropine
• Diazepam, clonazepam, temazepam, chlordiazepoxide, or triazolam
• Note: it is permitted to remain on the following psychoactive medications provided the subject has been receiving them for greater than or equal to 4 weeks:
• Antidepressants lacking significant anticholinergic side effects
• Estrogen replacement therapy

Where it is running

• Neurology Research Institute — West Palm Beach, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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