Alzheimer's DiseasePhase 2NCT04141150
Evaluation of [18F]APN-1607 PET Uptake in Alzheimer's Disease Patients Compared With Healthy Subjects
A Phase 2 study testing [18F]APN-1607 in people with Alzheimer's Disease and Mild Cognitive Impairment Due to Alzheimer's Disease, run by APRINOIA Therapeutics, LLC at 3 sites in United States.
Trial summary
The overall objective of this study is to compare the overall pattern of [18F]APN-1607 uptake in subjects with MDAD, subjects with AD dementia, and healthy subjects. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Mild Cognitive Impairment Due to Alzheimer's Disease, Healthy Volunteers
- What is being tested?
- [18F]APN-1607
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Mar 2022to Feb 2025
- Phase
- Phase 2
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females aged 50 to 85 years, inclusive.
- Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year (ie, 12 consecutive months with no menses without an alternative medical cause) or, if they are of childbearing potential, must commit to using a barrier contraception method or to abstinence for the duration of the study and must have a negative pregnancy test.
- Male subjects and their partners of childbearing potential must commit to the use of two methods of contraception, one of which is a barrier method (ie, condom), or to abstinence for the study duration.
- Male subjects must not donate sperm for the study duration.
- Willing and able to participate in all study procedures.
- Additional Inclusion Criteria for Healthy Subjects:
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- Written informed consent must be obtained before any assessment is performed.
- Medically healthy with no clinically relevant finding on physical examination, laboratory profiles, VS, or ECG at screening and upon reporting for the [18F]APN-1607 Imaging Visit.
- No cognitive impairment based on neuropsychological battery and as judged by the Investigator.
- No first-degree family history of early-onset AD or other neurodegenerative disease associated with dementia (prior to age 65).
- Has a clinical dementia rating (CDR) score of 0.
- Has an MMSE score ≥ 27.
- The subject has an appropriate informant to accompany the subject to screening to provide information for the CDR testing. In the event that the informant cannot accompany the subject to screening, the interview may be performed via phone, at the discretion of the site Investigator.
- Additional Inclusion Criteria for Subjects with MDAD:
- Written informed consent must be obtained before any assessment is performed.
- Must meet all of the clinical criteria for MCI according to NIA-AA criteria, including lack of functional impairment sufficient to warrant a diagnosis of dementia.
- Has a CDR score = 0.5.
- Has an MMSE score between 24 and 30, inclusive.
- Has a positive amyloid PET scan obtained during screening or in the past 1 year.
- Medications taken for symptomatic treatment of AD must have been stable for at least 30 days prior to screening and throughout the completion of the neuropsychological battery.
- The subject has an appropriate informant to provide information for the CDR and accompany the subject for any visits, if required for subject or staff comfort or safety.
- Additional Inclusion Criteria for Subjects with AD Dementia:
- Written informed consent must be obtained before any assessment is performed. If in the Investigator's opinion the subject lacks capacity to consent, participation is only possible if the subject has a legally authorized representative (LAR) or responsible next-of-kin and that individual provides written informed consent in accordance with local regulations and guidelines and the rules of the applicable independent ethics committee (IEC)/institutional review board (IRB). When written informed consent is provided by a LAR or responsible next of kin, the subject's assent must also be obtained and documented. For subjects judged lacking capacity to consent, next-of-kin consent in lieu of LAR consent is only allowed where permitted by local laws and regulations.
- Has a diagnosis of AD dementia according to NIA-AA criteria, including significant impairment of activities of daily living.
- Has a CDR score ≥ 0.5 at screening.
- Has an MMSE score between 10 and 26, inclusive.
- Has a positive amyloid PET scan obtained during screening or in the past 1 year.
- Medications taken for symptomatic treatment of AD must have been stable for 30 days prior to screening and throughout the completion of the neuropsychological battery.
- The subject has an appropriate informant to accompany the subject on all visits and provide information for the CDR.
Who cannot join
- Current or prior history (within the last 10 years) of alcohol or drug abuse.
- Known hypersensitivity to [18F]APN-1607 or its excipients
- Clinically significant active or unstable medical illness or planned surgical procedures during the study period. History of cancer (other than non-melanoma skin cancers or stable, local prostate cancer), unless without evidence of active disease within the last 3 years and without ongoing medical or surgical therapy.
- Laboratory tests with clinically significant abnormalities or a history or evidence of clinically significant unstable medical illness.
- Has received any investigational drug or device for any purpose within 30 days of screening (or 5 halflives of the drug, whichever is longer), has received a non-biologic investigational treatment (ie, small molecule) for AD or other cause of dementia within the last 3 months (or 5 half-lives of the drug, whichever is longer), or received a non-vaccine treatment (ie, monoclonal antibody) for the treatment of AD or other cause of dementia within the last 6 months, or has ever received a vaccine for the treatment of AD or other cause of dementia.
- Prior participation in other research protocols or clinical care in the last year in which the additional radiation exposure expected from participation in this clinical study will together exceed local guidelines, eg, above an effective dose of 50 mSv in the US.
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- Pregnant, lactating or breastfeeding.
- Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
- Unsuitable veins for repeated venipuncture.
- MRI exclusion criteria include: Findings that may be responsible for the neurologic status of the patient such as significant evidence of cerebrovascular disease (more than two lacunar infarcts, any territorial infarct >1cm3, or deep white matter abnormality corresponding to an overall Fazekas scale of 3 with at least one confluent hyperintense lesion on the fluid-attenuated inversion recovery (FLAIR) sequence that is ≥20 mm in any dimension), infectious disease, space-occupying lesions, normal pressure hydrocephalus or any other abnormalities associated with central nervous system (CNS) disease. For subjects with MDAD or AD dementia, there may be evidence of atrophy compatible with AD.
- Implants, such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI unless an acceptable MRI obtained in the 1 year prior to participation in the study is used.
- Signs or symptoms suggestive of active Coronavirus disease 2019 (COVID-19) and/or confirmed diagnosis of COVID-19, or positive COVID-19 polymerase chain reaction (PCR) test in the previous 2 weeks. These subjects should not be enrolled until 4 weeks after full recovery and further assessment by the Investigator per institutional guidelines. A subject with a known history of being exposed to someone who was diagnosed of COVID-19, during the prior 4 weeks, should not be enrolled unless the infection is excluded by local practice or institution.
- Meets criteria for a diagnosis of MDAD or dementia or has ever had such a diagnosis.
- Has ever received treatment with a drug for cognitive impairment or dementia.
- 1. Meets criteria for a diagnosis of dementia due to AD.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The NeuroCognitive Institute (Site 103), 111 Howard Blvd., Suite 204
Mount Arlington, New Jersey, 07856
Invicro (Site 100), 60 Temple Street, 8th Floor
New Haven, Connecticut, 06510
Columbia University Irving Center for Clinical and Translational Research (Site 105), 622 West 168th Street, PH-10th Floor
New York, New York, 10032
About this study
Official title: A Phase 2, Multicenter Study of [18F]APN-1607 Positron Emission Tomography in Subjects With Alzheimer's Disease Compared to Healthy Subjects
The overall objective of this study is to compare the overall pattern of [18F]APN-1607 uptake in subjects with MDAD, subjects with AD dementia, and healthy subjects.
Read the detailed description
The overall objective of this study is to compare the overall pattern of [18F]APN-1607 uptake in subjects with MDAD, subjects with AD dementia, and healthy subjects.
The specific objectives are:
- To expand the safety and tolerability profile for the administration of [18F]APN-1607 and PET scanning.
- To assess regional patterns of [18F]APN-1607 uptake.
- To determine the Braak stage equivalent reflected by [18F]APN-1607 uptake patterns.
- To evaluate the relationship between regional measures of [18F]APN-1607 uptake and demographic characteristics, eg, age and gender; biological characteristics, eg, apolipoprotein E epsilon 4 (APOE4) carrier status and measures of Aβ burden; and clinical characteristics, eg, measurements of AD disease severity, such as National Institute on Aging and Alzheimer's Association (NIA-AA) diagnosis, Mini-mental Status Exam (MMSE) score, and Alzheimer's Disease Assessment Scale-cognitive subscale (ADAScog).
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment Due to Alzheimer's Disease, Healthy Volunteers
- Being tested
- [18F]APN-1607
- Keywords
- AD, MDAD, HV
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]APN-1607Drug
In this study, all patients will receive one injection of [18F]APN-1607, a PET radiopharmaceutical selective for fibrillar tau. For the injection, subjects will receive a target dose of 7 mCi IV as a bolus injection. [18F]APN-1607 injection will be followed by a 10 ml saline flush.
| Study group | Role | What they receive |
|---|---|---|
| [18F]APN-1607 | Experimental | Subjects will undergo PET imaging using [18F]APN-1607. Receives: Drug: [18F]APN-1607 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of [18F]APN-1607 Uptake Patterns by Regional SUVR Values
Regional [18F]APN-1607 uptake patterns will be assessed in regions of interest (ROIs) and an iROI that are relevant to AD pathology. [18F]APN-1607 uptake patterns identified by regional analysis will be compared among healthy subjects, subjects with MDAD, and subjects with AD dementia. Standard uptake value (SUV) will be calculated for each ROI, and SUVRs will be calculated by normalizing SUV of ROIs to the SUV of relevant reference region. Mean and standard deviation of [18F]APN-1607 uptake (ie, SUVR) will be calculated across healthy, MDAD and AD dementia cohorts. Differences between groups will be tested at a P-value of 0.05 using statistical analyses methods (eg, unpaired t-test, ANOVA).
Measured: Day 7
Secondary outcomes (5)
Number of Adverse Events (AEs)
Measured by participants reporting AEs through non-directive questioning of the subject at each visit during the study or when volunteered by participants during or between visits.
Measured: Day 7
Number of Serious Adverse Events (SAEs)
Measured by participants reporting adverse events classified as serious
Measured: Day 7
Number of participants with vital sign abnormalities
Vital Sign measurements will include blood pressure, pulse rate, respiratory rate and body temperature.
Measured: Day 7
Number of participants with ECG abnormalities
Measured by 12-lead electrocardiogram
Measured: Day 7
Number of participants with clinical laboratory abnormalities
Measured by blood and urine analysis
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start22 Mar 2022
- Primary completionSep 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies 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 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- APRINOIA Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Russell, M.D., Ph.D, Principal investigator, Invicro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141150
- Sponsor's protocol ID
- APN-1607-201
- Status last verified
- Jun 2023
- First submitted
- 17 Oct 2019
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter Study of [18F]APN-1607 Positron Emission Tomography in Subjects With Alzheimer's Disease Compared to Healthy Subjects
- ClinicalTrials.gov ID
- NCT04141150
- Acronym / sponsor ID
- APN-1607-201
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment Due to Alzheimer's Disease, Healthy Volunteers
- Keywords
- AD, MDAD, HV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- APRINOIA Therapeutics, LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 28 Oct 2019 (actual)
- 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.
The overall objective of this study is to compare the overall pattern of [18F]APN-1607 uptake in subjects with MDAD, subjects with AD dementia, and healthy subjects.
Detailed description
The overall objective of this study is to compare the overall pattern of [18F]APN-1607 uptake in subjects with MDAD, subjects with AD dementia, and healthy subjects.
The specific objectives are:
- To expand the safety and tolerability profile for the administration of [18F]APN-1607 and PET scanning.
- To assess regional patterns of [18F]APN-1607 uptake.
- To determine the Braak stage equivalent reflected by [18F]APN-1607 uptake patterns.
- To evaluate the relationship between regional measures of [18F]APN-1607 uptake and demographic characteristics, eg, age and gender; biological characteristics, eg, apolipoprotein E epsilon 4 (APOE4) carrier status and measures of Aβ burden; and clinical characteristics, eg, measurements of AD disease severity, such as National Institute on Aging and Alzheimer's Association (NIA-AA) diagnosis, Mini-mental Status Exam (MMSE) score, and Alzheimer's Disease Assessment Scale-cognitive subscale (ADAScog).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]APN-1607 | Experimental | Drug: [18F]APN-1607Subjects will undergo PET imaging using [18F]APN-1607. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Males or females aged 50 to 85 years, inclusive.
- Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year (ie, 12 consecutive months with no menses without an alternative medical cause) or, if they are of childbearing potential, must commit to using a barrier contraception method or to abstinence for the duration of the study and must have a negative pregnancy test.
- Male subjects and their partners of childbearing potential must commit to the use of two methods of contraception, one of which is a barrier method (ie, condom), or to abstinence for the study duration.
- Male subjects must not donate sperm for the study duration.
- Willing and able to participate in all study procedures.
Key exclusion criteria (15 listed)
- Current or prior history (within the last 10 years) of alcohol or drug abuse.
- Known hypersensitivity to [18F]APN-1607 or its excipients
- Clinically significant active or unstable medical illness or planned surgical procedures during the study period. History of cancer (other than non-melanoma skin cancers or stable, local prostate cancer), unless without evidence of active disease within the last 3 years and without ongoing medical or surgical therapy.
- Laboratory tests with clinically significant abnormalities or a history or evidence of clinically significant unstable medical illness.
- Has received any investigational drug or device for any purpose within 30 days of screening (or 5 halflives of the drug, whichever is longer), has received a non-biologic investigational treatment (ie, small molecule) for AD or other cause of dementia within the last 3 months (or 5 half-lives of the drug, whichever is longer), or received a non-vaccine treatment (ie, monoclonal antibody) for the treatment of AD or other cause of dementia within the last 6 months, or has ever received a vaccine for the treatment of AD or other cause of dementia.
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 |
|---|---|---|
| [18F]APN-1607In this study, all patients will receive one injection of [18F]APN-1607, a PET radiopharmaceutical selective for fibrillar tau. For the injection, subjects will receive a target dose of 7 mCi IV as a bolus injection. [18F]APN-1607 injection will be followed by a 10 ml saline flush. | Drug | [18F]APN-1607 |
Primary outcome
Assessment of [18F]APN-1607 Uptake Patterns by Regional SUVR Values
Time frame: Day 7
Regional [18F]APN-1607 uptake patterns will be assessed in regions of interest (ROIs) and an iROI that are relevant to AD pathology. [18F]APN-1607 uptake patterns identified by regional analysis will be compared among healthy subjects, subjects with MDAD, and subjects with AD dementia. Standard uptake value (SUV) will be calculated for each ROI, and SUVRs will be calculated by normalizing SUV of ROIs to the SUV of relevant reference region. Mean and standard deviation of [18F]APN-1607 uptake (ie, SUVR) will be calculated across healthy, MDAD and AD dementia cohorts. Differences between groups will be tested at a P-value of 0.05 using statistical analyses methods (eg, unpaired t-test, ANOVA).
5 secondary outcomes
Number of Adverse Events (AEs)
Time frame: Day 7
Number of Serious Adverse Events (SAEs)
Time frame: Day 7
Number of participants with vital sign abnormalities
Time frame: Day 7
Number of participants with ECG abnormalities
Time frame: Day 7
Number of participants with clinical laboratory abnormalities
Time frame: Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Description Related InformationLink provided by the sponsor.
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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.
David Russell, M.D., Ph.D principal investigator
Invicro
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [18F]APN-1607 in people with Alzheimer's Disease and Mild Cognitive Impairment Due to Alzheimer's Disease, run by APRINOIA Therapeutics, LLC at 3 sites 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 29 inclusion and 15 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 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of [18F]APN-1607 Uptake Patterns by Regional SUVR Values (time frame: Day 7). 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 15 Jun 2023.