Alzheimer DiseasePhase 1NCT00657813
Evaluation of [123I] MNI-330 and SPECT as a Marker of Beta-amyloid Protein Deposition
A Phase 1 study testing MNI-330 as a brain SPECT tracer of Beta-Amyloid in people with Alzheimer Disease, run by Institute for Neurodegenerative Disorders at 1 site in United States.
Trial summary
The main objectives of this proposal are as follows: To assess the dynamic uptake and washout of 123-I MNI-330, a potential imaging biomarker for β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in similarly aged Alzheimer's (AD) subjects and healthy controls To perform blood… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- MNI-330 as a brain SPECT tracer of Beta-Amyloid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to 30 Sep 2008
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Alzheimer's Subject Selection. Subjects who have a clinical diagnosis of mild to moderate Alzheimer's disease will be recruited for this study. The following criteria will be met for inclusion of AD subjects in this study:
- The participant is 50 years or older.
- Written informed consent is obtained.
- Participants have a clinical diagnosis of Alzheimer's disease based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria.
- Mini-Mental Status Exam score < 25.
- Modified Hachinski Ischemia Scale score of ≤ 4.
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- Geriatric Depression Scales (GDS) ≤ 10.
- For females, non-child bearing potential or negative urine and blood pregnancy test on day of 123-I MNI-330 injection.
- Healthy Control Subject Selection. Healthy control subjects who have no neurological disease will be recruited for this study. The following criteria will be met for inclusion of healthy control subjects in this study:
- The participant is 50 years or older.
- Written informed consent is obtained.
- Negative history of neurological or psychiatric illness based on evaluation by a research physician.
- Mini-Mental Status Exam score ≥28.
- For females, non-child bearing potential or negative urine and blood pregnancy test on day of 123-I MNI-330 injection.
Who cannot join
- Alzheimer's subjects will be excluded from participation for the following reasons:
- The subject has signs or symptoms of another neurodegenerative disease including Parkinson's disease, diffuse Lewy body dementia, or history of significant cerebrovascular disease.
- The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
- The subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery).
- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- Pregnancy
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- Healthy control subjects will be excluded from participation for the following reasons:
- The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
- The subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery).
- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- Pregnancy
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: Evaluation of [123I] MNI-330 and Single Photon Emission Computed Tomography (SPECT) as a Marker of Beta-amyloid Protein Deposition in Subjects With Alzheimer Disease in Comparison to Healthy Subjects
The main objectives of this proposal are as follows:
To assess the dynamic uptake and washout of 123-I MNI-330, a potential imaging biomarker for β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in similarly aged Alzheimer's (AD) subjects and healthy controls
To perform blood metabolite characterization of 123-I MNI-330 in healthy and AD subjects to determine the metabolic fate and nature of metabolites in assessment of 123-I MNI-330 as a single photon computed tomography (SPECT) brain imaging agent
Evaluate the test/retest reproducibility of 123-I MNI-330 and SPECT in AD subjects and healthy controls
Read the detailed description
The underlying goal of this study is to assess 123-I MNI-330 SPECT imaging as a tool to detect ß-amyloid deposition in the brain of AD research participants and age- and gender-matched healthy subjects. All study procedures will be conducted at the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImaging (MNI) in New Haven, CT. Approximately 10 patients with Alzheimers disease (AD) and 6 healthy controls (within +/- 2 years) will be recruited to participate in this study. Healthy controls will be examined to ensure that there is no evidence of neurodegenerative changes including cognitive decline.
- Conditions
- Alzheimer Disease
- Being tested
- MNI-330 as a brain SPECT tracer of Beta-Amyloid
- Keywords
- Alzheimer, SPECT
- 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-330 as a brain SPECT tracer of Beta-AmyloidDrug
Each subject will receive a bolus injection targeted to be 5 miCi and not to exceed 5.5 mCi of MNI-330. Following injection serial dynamic imaging will be obtained over 8 hrs.
| Study group | Role | What they receive |
|---|---|---|
| Access [123I]MNI-330 and SPECT Imaging | Experimental | Not described Receives: Drug: MNI-330 as a brain SPECT tracer of Beta-Amyloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, 123-I MNI-330.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startMar 2008
- Primary completion30 Sep 2008
- Study completion30 Sep 2008
Why it stopped: Data did not evidence \[123I\]MNI-330 as a useful tool in the detection of AD.
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Neurodegenerative Disorders
- Sponsor type
- University, hospital or other
- Collaborators
- Molecular NeuroImaging
- Responsible party
- Sponsor
- Investigators
- Danna Jennings, MD, Principal investigator, Institute for Neurodegenerative Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657813
- Sponsor's protocol ID
- MNI-330-01
- Status last verified
- Apr 2019
- First submitted
- 8 Apr 2008
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of [123I] MNI-330 and Single Photon Emission Computed Tomography (SPECT) as a Marker of Beta-amyloid Protein Deposition in Subjects With Alzheimer Disease in Comparison to Healthy Subjects
- ClinicalTrials.gov ID
- NCT00657813
- Acronym / sponsor ID
- MNI-330-01
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer, SPECT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data did not evidence \[123I\]MNI-330 as a useful tool in the detection of AD.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Institute for Neurodegenerative DisordersUniversity, hospital or other
- Collaborators
- Molecular NeuroImaging
- Study start
- Mar 2008
- Primary completion
- 30 Sep 2008 (actual)
- Study completion
- 30 Sep 2008 (actual)
- First posted
- 14 Apr 2008 (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 main objectives of this proposal are as follows:
To assess the dynamic uptake and washout of 123-I MNI-330, a potential imaging biomarker for β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in similarly aged Alzheimer's (AD) subjects and healthy controls
To perform blood metabolite characterization of 123-I MNI-330 in healthy and AD subjects to determine the metabolic fate and nature of metabolites in assessment of 123-I MNI-330 as a single photon computed tomography (SPECT) brain imaging agent
Evaluate the test/retest reproducibility of 123-I MNI-330 and SPECT in AD subjects and healthy controls
Detailed description
The underlying goal of this study is to assess 123-I MNI-330 SPECT imaging as a tool to detect ß-amyloid deposition in the brain of AD research participants and age- and gender-matched healthy subjects. All study procedures will be conducted at the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImaging (MNI) in New Haven, CT. Approximately 10 patients with Alzheimers disease (AD) and 6 healthy controls (within +/- 2 years) will be recruited to participate in this study. Healthy controls will be examined to ensure that there is no evidence of neurodegenerative changes including cognitive decline.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Access [123I]MNI-330 and SPECT Imaging | Experimental | Drug: MNI-330 as a brain SPECT tracer of Beta-Amyloid |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Alzheimer's Subject Selection. Subjects who have a clinical diagnosis of mild to moderate Alzheimer's disease will be recruited for this study. The following criteria will be met for inclusion of AD subjects in this study:
- The participant is 50 years or older.
- Written informed consent is obtained.
- Participants have a clinical diagnosis of Alzheimer's disease based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria.
- Mini-Mental Status Exam score < 25.
Key exclusion criteria (11 listed)
- The subject has signs or symptoms of another neurodegenerative disease including Parkinson's disease, diffuse Lewy body dementia, or history of significant cerebrovascular disease.
- The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
- The subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery).
- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- Pregnancy
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-330 as a brain SPECT tracer of Beta-AmyloidEach subject will receive a bolus injection targeted to be 5 miCi and not to exceed 5.5 mCi of MNI-330. Following injection serial dynamic imaging will be obtained over 8 hrs. | Drug | Access [123I]MNI-330 and SPECT Imaging |
Primary outcome
The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, 123-I MNI-330.
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Data did not evidence \[123I\]MNI-330 as a useful tool in the detection of AD.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
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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 Phase 1 study testing MNI-330 as a brain SPECT tracer of Beta-Amyloid 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 14 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: stopped early, as of the sponsor's last update on 3 Apr 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?
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 was stopped early (reason given: Data did not evidence \[123I\]MNI-330 as a useful tool in the detection of AD.). 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?
The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, 123-I MNI-330. (time frame: 2 years). 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 3 Apr 2019.