Alzheimer DiseaseEarly Phase 1NCT03058965
Phase 0 Evaluation of [18F]MNI-958 as a Potential PET Radioligand for Imaging Tau Protein in the Brain
A Early Phase 1 study testing [18F]MNI-958, [18F]Florbetapir and DaTscan in people with Alzheimer Disease and Healthy Volunteers, run by Molecular NeuroImaging at 1 site in United States.
Trial summary
The overall goal of this imaging trial is to evaluate [18F]MNI-958, a tau targeted PET radioligand, in individuals with Alzheimer's disease (AD), Progressive Supranuclear Palsy (PSP), and healthy volunteers (HV). Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Healthy Volunteers, Progressive Supranuclear Palsy
- What is being tested?
- [18F]MNI-958, [18F]Florbetapir and DaTscan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2016to 11 May 2018
- Phase
- Early 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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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 or, if they are of child-bearing potential, must commit to use a barrier contraception 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
- Males and females aged ≥50 years. Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the [18F]MNI-958 imaging visit.
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- No cognitive impairment from neuropsychological battery as judged by the investigator
- Have screening [18F]florbetapir PET imaging demonstrating no significant amyloid binding based on qualitative analysis (visual read).
- No family history of Alzheimer's disease or neurological disease associated with dementia
- Have a CDR score=0
- Inclusion Criteria for subjects with a diagnosis of probable Alzheimer's disease (AD):
- Males and females aged 50 to 90 years.
- Have probable Alzheimer's disease, based on the NINCDS/ADRDA and DSM-IV criteria.
- Have a CDR score of 0.5 or greater at screening.
- Have an MMSE score ≤ 28.
- Have screening or prior (in the last 12 months) [18F]florbetapir PET imaging demonstrating amyloid binding based on qualitative (visual read)
- A brain MRI that supports a diagnosis of AD, with no evidence of focal disease to account for dementia or MRI exclusion criteria.
- Medications taken for symptomatic treatment of AD must be maintained on a stable dosage regimen for at least 30 days before the screening visit.
- Signed and dated written informed consent obtained from the subject and the subject's legally authorized representative or caregiver (if applicable).
- The subject has an appropriate caregiver capable of accompanying subject, if necessary.
- Inclusion Criteria for subjects with a diagnosis of probable Progressive Suprnuclear Palsy (PSP)
- Males and females aged 50 to 90 years.
- Has a clinical diagnosis of PSP based on the NINDS and Society for PSP criteria (Litvan, et al 1996).
- Have screening or prior DaTscan SPECT imaging demonstrating evidence of dopamine transporter deficit based on visual read.
- A brain MRI that supports a diagnosis of PSP, with no other evidence of significant neurologic pathology
- Medications taken for symptomatic treatment of PSP 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).
- The subject has an appropriate caregiver capable of accompanying subject, if necessary.
Who cannot join
- Current or prior history of any alcohol or drug abuse.
- 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.
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- Unsuitable veins for repeated venipuncture.
- MRI exclusion criteria include: 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.
- Has received treatment that targeted amyloid-β or tau within the last 3 months.
- Ongoing treatment with methylphenidate, bupropion, modafinil, metoclopramide, alpha methyldopa, reserpine, or amphetamine derivative.
Trial locations and contacts
1 site in 1 country.
United States1 site
Molecular NeuroImaging, LLC
New Haven, Connecticut, 06510
About this study
Official title: Phase 0 Evaluation of [18F]MNI-958 as a Potential PET Radioligand for Imaging Tau Protein in the Brain of Patients With Probable Alzheimer's Disease or Progressive Supranuclear Palsy Compared With Healthy Volunteers
The overall goal of this imaging trial is to evaluate [18F]MNI-958, a tau targeted PET radioligand, in individuals with Alzheimer's disease (AD), Progressive Supranuclear Palsy (PSP), and healthy volunteers (HV).
- Being tested
- [18F]MNI-958, [18F]Florbetapir, DaTscan
- Keywords
- AD, HV, PSP
- Medical subject headings
- Alzheimer Disease, Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]MNI-958Drug
Subjects will undergo PET imaging using [18F]MNI-958, a PET radioligand for imaging tau.
[18F]FlorbetapirDrug
Subjects with Alzheimer's disease will receive a [18F]florbetapir scan to compare distribution of tau in the brain compared to that of [18F]MNI-958.
DaTscanDrug
DaTscan SPECT imaging will be completed in those PSP subjects who have not previously had DATScan imaging as part of the screening procedures.
| Study group | Role | What they receive |
|---|---|---|
| [18F]MNI-958 | Experimental | To evaluate [18F]MNI-958, a tau targeted PET radioligand. Receives: Drug: [18F]MNI-958; Drug: [18F]Florbetapir; Drug: DaTscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracer uptake will be evaluated in regions of interest for analysis of regional [18F]MNI-958 binding/uptake and expressed in SUV by using established methods for normalization for 3 AD, 3 PSP, and 3 HV subjects.
Descriptive statistics will be applied to describe the tau deposition by region as measured by [18F]MNI-958.
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 posted23 Feb 2017
- Study start29 Nov 2016
- Primary completion11 May 2018
- Study completion11 May 2018
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
- Early 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
- Molecular NeuroImaging
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058965
- Sponsor's protocol ID
- [18F]MNI-958
- Status last verified
- Mar 2019
- First submitted
- 12 Jan 2017
- Last updated
- 25 Mar 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 0 Evaluation of [18F]MNI-958 as a Potential PET Radioligand for Imaging Tau Protein in the Brain of Patients With Probable Alzheimer's Disease or Progressive Supranuclear Palsy Compared With Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03058965
- Acronym / sponsor ID
- [18F]MNI-958
- Keywords
- AD, HV, PSP
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Molecular NeuroImagingUniversity, hospital or other
- Study start
- 29 Nov 2016 (actual)
- Primary completion
- 11 May 2018 (actual)
- Study completion
- 11 May 2018 (actual)
- First posted
- 23 Feb 2017 (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 goal of this imaging trial is to evaluate [18F]MNI-958, a tau targeted PET radioligand, in individuals with Alzheimer's disease (AD), Progressive Supranuclear Palsy (PSP), and healthy volunteers (HV).
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-958 | Experimental | Drug: [18F]MNI-958, Drug: [18F]Florbetapir, Drug: DaTscanTo evaluate [18F]MNI-958, a tau targeted PET radioligand. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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 or, if they are of child-bearing potential, must commit to use a barrier contraception 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 (11 listed)
- Current or prior history of any alcohol or drug abuse.
- 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.
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-958Subjects will undergo PET imaging using [18F]MNI-958, a PET radioligand for imaging tau. | Drug | [18F]MNI-958 |
| [18F]FlorbetapirSubjects with Alzheimer's disease will receive a [18F]florbetapir scan to compare distribution of tau in the brain compared to that of [18F]MNI-958. | Drug | [18F]MNI-958 |
| DaTscanDaTscan SPECT imaging will be completed in those PSP subjects who have not previously had DATScan imaging as part of the screening procedures. | Drug | [18F]MNI-958 |
Primary outcome
Tracer uptake will be evaluated in regions of interest for analysis of regional [18F]MNI-958 binding/uptake and expressed in SUV by using established methods for normalization for 3 AD, 3 PSP, and 3 HV subjects.
Time frame: 1 year
Descriptive statistics will be applied to describe the tau deposition by region as measured by [18F]MNI-958.
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 25 Mar 2019.
- Related InfoLink 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [18F]MNI-958, [18F]Florbetapir and DaTscan in people with Alzheimer Disease and Healthy Volunteers, run by Molecular NeuroImaging 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 11 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 25 Mar 2019. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Tracer uptake will be evaluated in regions of interest for analysis of regional [18F]MNI-958 binding/uptake and expressed in SUV by using established methods for normalization for 3 AD, 3 PSP, and 3 HV subjects. (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 25 Mar 2019.