Mild Cognitive ImpairmentPhase 1NCT02928211
Aftobetin-HCl and Fluorescence Detection Measured by Sapphire II to Determine the Number and Timing of Administrations
A Phase 1 study testing Sapphire II, Aftobetin-HCl and Positron Emission Tomography in people with Mild Cognitive Impairment and Alzheimer's Disease, run by Cognoptix, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer's Disease
- What is being tested?
- Sapphire II, Aftobetin-HCl and Positron Emission Tomography
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jan 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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;
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- 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
- Gingko biloba
- Sedative hypnotics: lorazepam, buspirone, oxazepam, zolpidem, zaleplon, alprazolam, chloral hydrate
- Note: it is permitted to remain on the following psychoactive medications provided the subject has been receiving them for greater than or equal to 12 weeks:
- Cholinesterase inhibitors
- Memantine Note: the washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics) must be at least 4 weeks prior to screening.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Neurology Research Institute
West Palm Beach, Florida, 33407
Teresa Villena, 561-845-0500, tvillena@aol.com
About this study
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
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.
Read the 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
- Being tested
- Sapphire II, Aftobetin-HCl, Positron Emission Tomography
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sapphire IIDevice
A Class 1 laser device used in conjunction with the ointment to measure fluorescence emissions from the anterior segment (lens) of the eye.
Aftobetin-HClDrug
Also called medical imaging agent, ointment
The medical imaging agent (the ointment), Aftobetin-HCl is an amyloid binding ligand formulated into an ophthalmic ointment.
Positron Emission TomographyRadiation
Also called PET
Amyvid 370 MBq (10 mCi) is administered as a single bolus through a short intravenous catheter in a total volume of 10 mL.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | All subjects will receive the ointment and have scans with the Sapphire II device Receives: Device: Sapphire II; Drug: Aftobetin-HCl; Radiation: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paired pre-ligand and post ligand fluorescent uptake values (FUV)
Measured: through study completion, approximately 4 weeks
Determination of success (yes or no)
Determination of success (yes or no) associated with FUVs obtained after one dose or two doses of ligand at each time point by subject
Measured: through study completion, approximately 4 weeks
The overall diagnostic precision for each combination of Aftobetin-HCl administrations and Fluorescent Uptake Value (FUV)
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.
Measured: through study completion, approximately 4 weeks
Secondary outcomes (5)
Estimates of sensitivity and specificity of MCI and mild AD subjects compared to cognitively normal subjects
Measured: through study completion, approximately 4 weeks
Safety of Sapphire II procedure as determined by instances of Adverse Events
Measured: through the follow up safety visit, approximately 4 weeks
Characterization of maximal fluorescence after 1, or potentially 3, ointment administrations
Measured: 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
Optional repeatability portion of the study
Measured: through study completion, approximately 6 weeks
Correlation of FUV to PET amyloid status
Measured: through study completion, approximately 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cognoptix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joyce Myers, MD, Study director, Cognoptix, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928211
- Sponsor's protocol ID
- PRT-0036
- Status last verified
- Aug 2018
- First submitted
- 19 Sep 2016
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Subjects will receive copies of their PET scans following completion of their participation in the study
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02928211
- Acronym / sponsor ID
- PRT-0036
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Cognoptix, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 10 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Sapphire II, Drug: Aftobetin-HCl, Radiation: Positron Emission TomographyAll subjects will receive the ointment and have scans with the Sapphire II device |
Who may qualify
- Ages
- 25 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (30 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sapphire IIA Class 1 laser device used in conjunction with the ointment to measure fluorescence emissions from the anterior segment (lens) of the eye. | Device | Experimental |
| Aftobetin-HClAlso: medical imaging agent, ointmentThe medical imaging agent (the ointment), Aftobetin-HCl is an amyloid binding ligand formulated into an ophthalmic ointment. | Drug | Experimental |
| Positron Emission TomographyAlso: PETAmyvid 370 MBq (10 mCi) is administered as a single bolus through a short intravenous catheter in a total volume of 10 mL. | Radiation | Experimental |
Primary outcome
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.
5 secondary outcomes
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
Correlation of FUV to PET amyloid status
Time frame: through study completion, approximately 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Individual participant dataSharing planned: Yes. Subjects will receive copies of their PET scans following completion of their participation in the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joyce Myers, MD study director
Cognoptix, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sapphire II, Aftobetin-HCl and Positron Emission Tomography in people with Mild Cognitive Impairment and Alzheimer's Disease, run by Cognoptix, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dennis Nilan ((978) 263-0005, info@cognoptix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paired pre-ligand and post ligand fluorescent uptake values (FUV) (time frame: through study completion, approximately 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.