Alzheimer DiseaseEarly Phase 1NCT01000870
Safety and Efficacy of Positron Emission Tomography Imaging With MNI-513
A Early Phase 1 study testing MNI-513-01 in people with Alzheimer Disease, run by Institute for Neurodegenerative Disorders at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of MNI-513 positron emission tomography (PET) for detection/exclusion of cerebral amyloid beta in patients with Alzheimer's disease compared to healthy volunteers. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- MNI-513-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Sep 2010
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- is a man or woman and is ≥ 55 of age, whereby females must be without childbearing potential (confirmed by either: age ≥ 60; or history of surgical sterilization or of hysterectomy, or last spontaneous bleeding at least 2 years prior to the study start)
- has at least 6 years of education
- is able to provide informed consent or assent, and exhibits adequate visual, auditory and communication capabilities to enable compliance with study procedures. This includes performing the psychometric testing and being able to lie down flat in the PET scanner
- possesses a general health that permits adequate compliance with all study procedures as ascertained by a detailed review of the medical history, laboratory and physical examination findings, which must be performed within 28 days prior to administration of IMP
- the subject, or the subject and caregiver (for probable AD patients) will be compliant and have a high probability of completing the study in the opinion of the investigator
- informed consent has been signed and dated (with time) by the subject and/or the subject's caregiver (for probable AD patients)
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- has no evidence of cognitive impairment as indicated by a clinical dementia rating (CDR, [Hughes et al. 1993]) score of 0 (zero) and a score of ≥ 28 in the Mini-Mental Status Examination (MMSE, [Folstein et al. 1975])
- has in the CERAD neuropsychological test battery [Welsh et al. 1994] a z- score of
- ≥ (-1.00) for each subtest (except for the MMSE which is covered by criterion 1 above)
- has MRI brain scan that has been judged as "normal (age- appropriate)" including ARWMC scale [Wahlund et al. 2001] scores supporting the lack of cerebrovascular disease (e.g., a white matter lesion score of 0 or 1 or 2 and a basal ganglia score of 0 or 1) and a Scheltens scale [Scheltens et al. 1992] verifying the lack of cerebral atrophy (e.g. bilateral temporal lobe atrophy visual score of 0 or 1)
- presents with positive assessment for dementia of Alzheimer's type in accordance with the DSM-IV-TR and probable AD according to the NINCDS-ADRDA criteria and fulfils none of the exclusion criteria of either (see Appendix 1,2)
- does not fulfill the ICC criteria for probable DLB (Appendix 3), the NINDS-AIREN for probable Vascular dementia (Appendix 5), or the Neary [Neary et al. 1998] criteria for FTD (Appendix 4)
- has a CDR [Hughes et al. 1993] score of 0.5, 1 or 2
- MRI brain scan findings that do not reveal changes indicative of stroke and/or generalized cerebrovascular disease (e.g., the ARWMC scale) changes limited to: a white matter lesion score of 0 or 1 or 2 and a basal ganglia score of 0 or 1)
- has a caregiver who is willing and able to attend all study visits and perform the psychometric tests requiring the presence of a caregiver
Who cannot join
- has any contraindication to MRI examination, e.g. metal implants or phobia as determined by the onsite radiologist performing the scan
- is scheduled for surgery and/or another invasive procedure within the time period of up to 24 hours following IMP application
- is allergic to the IMP or any of its constituents and/or has a history of severe allergic reactions to drugs or allergens (e.g. patients / volunteers with allergic asthma)
- is critically ill and/or medically unstable and whose clinical course during the observation period is unpredictable, e.g. patients / volunteers within 14 days of myocardial infarction or stroke, unstable patients / volunteers with previous surgery (within 7 days), patients with advanced heart insufficiency (NYHA stage IV), or with acute renal failure
- has a history of exposure to any radiation >15 mSv/year (e.g. occupational or radiation therapy)
- is receiving drug therapy or other treatment that is known to lead to greatly fluctuating values of the hematological or chemical laboratory parameters or to severe side effects (e.g. chemotherapy)
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- has received anti-amyloid drug therapy.
- has received any contrast material (X-ray, MRI) or radiopharmaceuticals within 48 hours prior to the application of the IMP or for whom application of such a substance is planned for the 24 hours following IMP administration
- has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening, and/or any radiopharmaceutical within 10 radioactive half-lives prior to IMP administration
- has a brain tumor or other intracranial lesion, a disturbance of CSF circulation (e.g., normal pressure hydrocephalus) and/or a history of head trauma or brain surgery
- has an inflammatory or infectious CNS disease, e.g. multiple sclerosis, HIV, syphilis, or Creutzfeld-Jacob disease
- has a history, physical, laboratory or imaging findings indicative of a significant neurological or psychiatric illness (for patients - other than AD)
- has another disease that can cause disturbance of brain function (e.g. vitamin B12 or folic acid deficiency, disturbed thyroid function)
- has a history of alcohol or drug abuse 15 has history of severe persistent depression
- 16.clinically significant hematologic indices that may put subject at increased risk for bleeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510
About this study
Official title: An Exploratory, Open-label, Non-randomized Phase 0 Study to Evaluate Efficacy & Safety of MNI-513 Positron Emission Tomography for Detection/Exclusion of Cerebral Amyloid Beta in Patients w/ Alzheimer Disease Compared to Healthy Volunteers
The purpose of the study is to evaluate the efficacy and safety of MNI-513 positron emission tomography (PET) for detection/exclusion of cerebral amyloid beta in patients with Alzheimer's disease compared to healthy volunteers.
Read the detailed description
To determine diagnostic efficacy of the MNI-513 PET scans in differentiating between patients with probable AD and HVs on the basis of neocortical tracer binding pattern, the PET scans will be visually assessed by a nuclear physician experienced in the field of neuro-imaging. PET scan findings will be classified either as abnormal (i.e., significant neocortical uptake in predefined regions) or as normal (i.e. no significant neocortical uptake in predefined regions). The nuclear physician will be unaware of the clinical diagnosis.
- Conditions
- Alzheimer Disease
- Being tested
- MNI-513-01
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MNI-513-01Drug
Subjects will be administered a single IV injection of IMP with a total activity amounting to 300MBq (8.1 mCi) +/- 20% of MNI-513 followed by PET imaging.
| Study group | Role | What they receive |
|---|---|---|
| Access MNI-513 and PET Imaging | Experimental | Not described Receives: Drug: MNI-513-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy and safety of MNI-513 positron emission tomography (PET) for detection/exclusion of cerebral amyloid beta in patients with Alzheimer's disease compared to healthy volunteers
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 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: Results did not show reason to continue with study
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Neurodegenerative Disorders
- Sponsor type
- University, hospital or other
- Investigators
- Danna Jennings, MD, Principal investigator, Institute for Neurodegenerative Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000870
- Sponsor's protocol ID
- MNI-513-01
- Status last verified
- Oct 2010
- First submitted
- 22 Oct 2009
- Last updated
- 6 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Open-label, Non-randomized Phase 0 Study to Evaluate Efficacy & Safety of MNI-513 Positron Emission Tomography for Detection/Exclusion of Cerebral Amyloid Beta in Patients w/ Alzheimer Disease Compared to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01000870
- Acronym / sponsor ID
- MNI-513-01
- Conditions
- Alzheimer Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Results did not show reason to continue with study
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Institute for Neurodegenerative DisordersUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 23 Oct 2009 (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.
The purpose of the study is to evaluate the efficacy and safety of MNI-513 positron emission tomography (PET) for detection/exclusion of cerebral amyloid beta in patients with Alzheimer's disease compared to healthy volunteers.
Detailed description
To determine diagnostic efficacy of the MNI-513 PET scans in differentiating between patients with probable AD and HVs on the basis of neocortical tracer binding pattern, the PET scans will be visually assessed by a nuclear physician experienced in the field of neuro-imaging. PET scan findings will be classified either as abnormal (i.e., significant neocortical uptake in predefined regions) or as normal (i.e. no significant neocortical uptake in predefined regions). The nuclear physician will be unaware of the clinical diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Access MNI-513 and PET Imaging | Experimental | Drug: MNI-513-01 |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- is a man or woman and is ≥ 55 of age, whereby females must be without childbearing potential (confirmed by either: age ≥ 60; or history of surgical sterilization or of hysterectomy, or last spontaneous bleeding at least 2 years prior to the study start)
- has at least 6 years of education
- is able to provide informed consent or assent, and exhibits adequate visual, auditory and communication capabilities to enable compliance with study procedures. This includes performing the psychometric testing and being able to lie down flat in the PET scanner
- possesses a general health that permits adequate compliance with all study procedures as ascertained by a detailed review of the medical history, laboratory and physical examination findings, which must be performed within 28 days prior to administration of IMP
- the subject, or the subject and caregiver (for probable AD patients) will be compliant and have a high probability of completing the study in the opinion of the investigator
Key exclusion criteria (15 listed)
- has any contraindication to MRI examination, e.g. metal implants or phobia as determined by the onsite radiologist performing the scan
- is scheduled for surgery and/or another invasive procedure within the time period of up to 24 hours following IMP application
- is allergic to the IMP or any of its constituents and/or has a history of severe allergic reactions to drugs or allergens (e.g. patients / volunteers with allergic asthma)
- is critically ill and/or medically unstable and whose clinical course during the observation period is unpredictable, e.g. patients / volunteers within 14 days of myocardial infarction or stroke, unstable patients / volunteers with previous surgery (within 7 days), patients with advanced heart insufficiency (NYHA stage IV), or with acute renal failure
- has a history of exposure to any radiation >15 mSv/year (e.g. occupational or radiation therapy)
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 |
|---|---|---|
| MNI-513-01Subjects will be administered a single IV injection of IMP with a total activity amounting to 300MBq (8.1 mCi) +/- 20% of MNI-513 followed by PET imaging. | Drug | Access MNI-513 and PET Imaging |
Primary outcome
To evaluate the efficacy and safety of MNI-513 positron emission tomography (PET) for detection/exclusion of cerebral amyloid beta in patients with Alzheimer's disease compared to healthy volunteers
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Results did not show reason to continue with study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2010.
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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.
Danna Jennings, MD principal investigator
Institute for Neurodegenerative Disorders
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 MNI-513-01 in people with Alzheimer Disease, run by Institute for Neurodegenerative Disorders 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 15 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: stopped early, as of the sponsor's last update on 6 Oct 2010. 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 was stopped early (reason given: Results did not show reason to continue with 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?
To evaluate the efficacy and safety of MNI-513 positron emission tomography (PET) for detection/exclusion of cerebral amyloid beta in patients with Alzheimer's disease compared to healthy volunteers (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 6 Oct 2010.