Alzheimer DiseasePhase 1NCT03587649
Evaluation of [18F]MNI-1126 as an Imaging Marker for Synaptic Density Loss
A Phase 1 study testing [18F]MNI-1126 in people with Alzheimer Disease and Parkinson Disease, run by Invicro at 1 site in United States.
Trial summary
The primary objective of this protocol is to examine [18F]MNI-1126 as a tool to assess synaptic density loss. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Parkinson Disease, Healthy Volunteers
- What is being tested?
- [18F]MNI-1126
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2018to 26 Feb 2020
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent must be obtained before any assessment is performed.
- 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 (i.e. 12 consecutive months with no menses without an alternative medical cause) or, if they are of child-bearing potential, must commit to use two methods of contraception, one of which is a barrier method for the duration of the study.
- 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 for male subjects for the study duration.
- Male subjects must not donate sperm for the study duration.
- Willing and able to cooperate with study procedures.
- For females, non-child bearing potential or negative urine pregnancy test on day of [18F]MNI-1126 injection.
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- Are males or females ≥ 30 years of age.
- Must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia.
- Have Hoehn and Yahr stage ≤3.
- Have a MMSE score ≥ 22.
- PD subjects may be treated with PD symptomatic therapy on a stable dose of medications for a period of at least 30 days prior to the [18F]MNI-1126 PET imaging visit.
- Have screening or prior DaTscan SPECT imaging demonstrating evidence of dopamine transporter deficit based on visual read.
- Healthy volunteers inclusion criteria:
- Males and females aged ≥50 years. Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the [18F]MNI-1126 imaging visit.
- No cognitive impairment from neuropsychological battery as judged by the investigator.
- Have screening or prior ( in the last 12 months ) amyloid PET imaging demonstrating no significant amyloid binding based on qualitative (visual read).
- No family history of Alzheimer's disease or neurological disease associated with dementia.
- Have a CDR global score=0.
- Have an MMSE score ≥28.
- Inclusion criteria for subjects with a diagnosis of probable Alzheimer's disease (AD):
- Males and females aged 50 to 80 years.
- Have probable Alzheimer's disease dementia, based on the NINCDS/ADRDA and DSM-IV criteria, with mild severity and amnestic presentation.
- Have a CDR score ≥ 0.5 at screening.
- Have a MMSE score ≤ 28.
- Have screening or prior (in the last 12 months) amyloid PET imaging demonstrating amyloid binding based on qualitative analysis (visual read). Amyloid PET imaging results will be shared with participants, and scans may be used by participants for future research use.
- A brain MRI that supports a diagnosis of AD, with no evidence of significant neurologic pathology (see exclusion criteria).
- Medications taken for symptomatic treatment of AD must be maintained on a stable dosage regimen for at least 30 days before screening visit.
- Signed and dated written informed consent obtained from the subject and the subject's legally authorized representative or caregiver (if applicable).
Who cannot join
- Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical illness.
- Subject has received an investigational drug or device within 30 days of screening
- Prior participation in other research protocols or clinical care in the last year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds the effective dose of 50 mSv, which would be above the acceptable annual limit established by the US Federal Guidelines.
- Pregnancy, 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.
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- 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 FLAIR sequence that is ≥20 mm in any dimension), infectious disease, space-occupying lesions, normal pressure hydrocephalus or any other abnormalities associated with CNS disease.
- 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.
- Are claustrophobic or otherwise unable to tolerate the imaging procedure
- Has received treatment that targeted Aβ or tau within the last 3 months.
- Ongoing treatment with methylphenidate, modafinil, metoclopramide, alpha methyldopa, reserpine, or amphetamine derivative for subjects requiring DaTscan imaging.
- Subjects may take stable doses of bupropion, however this medication must be held for at least 12 hours prior to DaTscan imaging.
- Subject has known hypersensitivity to iodine or potassium iodide (KI) in the opinion of the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of [18F]MNI-1126 as an Imaging Marker for Synaptic Density Loss in the Brain of Patients With Probable Alzheimer's Disease, Probable Parkinson's Disease (PD) Subjects as Compared to Healthy Volunteers (HV).
The primary objective of this protocol is to examine [18F]MNI-1126 as a tool to assess synaptic density loss.
Read the detailed description
The primary objective of this protocol is to examine [18F]MNI-1126 as a tool to assess synaptic density loss.The specific objectives are:
- Examine [18F]MNI-1126 as a tool to assess synaptic density loss.
- To measure the dynamic uptake and washout of [18F]MNI-1126 in the brain using positron emission tomography (PET) in subjects with AD, PD, and healthy volunteers.
- To measure blood metabolites of [18F]MNI-1126 and perform kinetic modeling to assess its ability to measure synaptic density loss in the brain using the tracer plasma concentration or a reference region as indirect input.
- To acquire safety data following injection of [18F]MNI-1126.
- Conditions
- Alzheimer Disease, Parkinson Disease, Healthy Volunteers
- Being tested
- [18F]MNI-1126
- Keywords
- AD, PD, HV
- Medical subject headings
- Alzheimer Disease, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]MNI-1126Drug
Florbetapir PET imaging will be completed in all healthy volunteers and AD subjects as part of the screening procedures.
DaTscan SPECT imaging will be completed in those PDsubjects who have not previously had DaTscan imaging as part of the screening procedures.
| Study group | Role | What they receive |
|---|---|---|
| [18F]MNI-1126 | Experimental | To measure the dynamic uptake and washout of [18F]MNI-1126 in the brain using positron emission tomography (PET) in subjects with AD, PD, and healthy volunteers. Receives: Drug: [18F]MNI-1126 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regions in the VOI template will be used to quantify the regional tracer uptake and used for comparison of potential uptake differences across the different groups.
Descriptive statistics will be applied to describe the tau deposition by region as measured by [18F]MNI-1126.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start7 May 2018
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer 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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invicro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Russell, M.D., Ph. D, Principal investigator, Invicro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587649
- Sponsor's protocol ID
- [18F]MNI-1126
- Status last verified
- Apr 2020
- First submitted
- 3 Jul 2018
- Last updated
- 15 Apr 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of [18F]MNI-1126 as an Imaging Marker for Synaptic Density Loss in the Brain of Patients With Probable Alzheimer's Disease, Probable Parkinson's Disease (PD) Subjects as Compared to Healthy Volunteers (HV).
- ClinicalTrials.gov ID
- NCT03587649
- Acronym / sponsor ID
- [18F]MNI-1126
- Conditions
- Alzheimer Disease, Parkinson Disease, Healthy Volunteers
- Keywords
- AD, PD, HV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- InvicroUniversity, hospital or other
- Study start
- 7 May 2018 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 16 Jul 2018 (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 primary objective of this protocol is to examine [18F]MNI-1126 as a tool to assess synaptic density loss.
Detailed description
The primary objective of this protocol is to examine [18F]MNI-1126 as a tool to assess synaptic density loss.The specific objectives are:
- Examine [18F]MNI-1126 as a tool to assess synaptic density loss.
- To measure the dynamic uptake and washout of [18F]MNI-1126 in the brain using positron emission tomography (PET) in subjects with AD, PD, and healthy volunteers.
- To measure blood metabolites of [18F]MNI-1126 and perform kinetic modeling to assess its ability to measure synaptic density loss in the brain using the tracer plasma concentration or a reference region as indirect input.
- To acquire safety data following injection of [18F]MNI-1126.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]MNI-1126 | Experimental | Drug: [18F]MNI-1126To measure the dynamic uptake and washout of [18F]MNI-1126 in the brain using positron emission tomography (PET) in subjects with AD, PD, and healthy volunteers. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (28 listed)
- Written informed consent must be obtained before any assessment is performed.
- 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 (i.e. 12 consecutive months with no menses without an alternative medical cause) or, if they are of child-bearing potential, must commit to use two methods of contraception, one of which is a barrier method for the duration of the study.
- 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 for male subjects for the study duration.
- Male subjects must not donate sperm for the study duration.
- Willing and able to cooperate with study procedures.
Key exclusion criteria (13 listed)
- Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical illness.
- Subject has received an investigational drug or device within 30 days of screening
- Prior participation in other research protocols or clinical care in the last year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds the effective dose of 50 mSv, which would be above the acceptable annual limit established by the US Federal Guidelines.
- Pregnancy, lactating or breastfeeding.
- Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
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]MNI-1126Florbetapir PET imaging will be completed in all healthy volunteers and AD subjects as part of the screening procedures. DaTscan SPECT imaging will be completed in those PDsubjects who have not previously had DaTscan imaging as part of the screening procedures. | Drug | [18F]MNI-1126 |
Primary outcome
Regions in the VOI template will be used to quantify the regional tracer uptake and used for comparison of potential uptake differences across the different groups.
Time frame: 1 year
Descriptive statistics will be applied to describe the tau deposition by region as measured by [18F]MNI-1126.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Invicro home pageLink 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
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 [18F]MNI-1126 in people with Alzheimer Disease and Parkinson Disease, run by Invicro 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 28 inclusion and 13 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: finished, as of the sponsor's last update on 15 Apr 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Regions in the VOI template will be used to quantify the regional tracer uptake and used for comparison of potential uptake differences across the different groups. (time frame: 1 year). 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 Apr 2020.