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Alzheimer's DiseasePhase 1NCT01859767

Efficacy and Safety of MNI-672 SPECT for Detection/Exclusion of Cerebral B-amyloid in AD Subjects Compared to HVs.

A Phase 1 study testing [123I]MNI-672 SPECT in people with Alzheimer's Disease, run by Molecular NeuroImaging at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 1, single center, open-label, non-randomized, clinical study in probable AD patients and HVs to evaluate the efficacy, safety and tolerability of a single dose of MNI-672. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Alzheimer's Disease
What is being tested?
[123I]MNI-672 SPECT
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
Apr 2013to Apr 2015
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 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • has any contraindication to MRI examination, e.g. metal implants or phobia
  • is scheduled for surgery and/or another invasive procedure within the time period of up to 7 days following MNI-672 application
  • is 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)
  • has received anti-amyloid drug therapy
Show all 11Show fewer
  • 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 MNI-672 administration
  • has a brain tumor or other intracranial lesion, a disturbance of CSF circulation (e.g., normal pressure hydrocephalus) and/or a history of serious head trauma or brain surgery
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Molecular NeuroImaging, LLC

    New Haven, Connecticut, 06510

Other trials in United States

About this study

Official title: An Exploratory, Open-label, Non-randomized Phase 1 Study to Evaluate the Efficacy and Safety of MNI-672 SPECT for Detection/Exclusion of Cerebral B-amyloid in Patients With Alzheimer's Disease Compared to Healthy Volunteers.

This is a Phase 1, single center, open-label, non-randomized, clinical study in probable AD patients and HVs to evaluate the efficacy, safety and tolerability of a single dose of MNI-672. The underlying goal of this study is to assess MNI-672 SPECT imaging as a tool to detect ß amyloid deposition in the brain of AD research participants and young healthy male subjects. All study procedures will be conducted at Molecular NeuroImaging (MNI) in New Haven, CT. Approximately 3 patients with AD and 3 young male HVs will be recruited to participate in this study. HVs will be screened to ensure that there is no evidence of cognitive decline or significant neurological deficit.

All eligible subjects will be required to visit the study center on at least 2 occasions:

  1. for one or more screening visits which should include a history and physical examination, laboratory and extensive neuro-psychological testing and MRI brain scanning. AD subjects will also undergo Amyvid PET imaging as part of the Screening Visit.
  2. on one day for baseline examinations and MNI-672 administration and subsequent SPECT scanning- followed by safety measures
Read the detailed description

To determine diagnostic efficacy of the MNI-672 SPECT scans in differentiating between patients with probable AD and HVs on the basis of neocortical tracer binding pattern, the SPECT scans will be visually assessed by a nuclear physician experienced in the field of neuro-imaging. SPECT 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 visual analysis of the MNI SPECT images will be compared to the clinical diagnosis and Amyvid PET imaging results to determine the efficacy of MNI-672 as an agent to detect B-amyloid. The nuclear physician evaluating the SPECT images will be unaware of the clinical diagnosis.

Being tested
[123I]MNI-672 SPECT
Keywords
Alzheimer's disease, 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.

  • [123I]MNI-672 SPECTDrug

    Also called MNI-672

    Subjects will be dosed by intravenous injection to a target dose of 5 mCi and not to exceed 5.5 (not >10% of 5 mCi limit) I-123 MNI-672 prior to the SPECT scan.

Study groups in NCT01859767
Study groupRoleWhat they receive
[123I]MNI-672 SPECTExperimental[123I]MNI-672 single photon emission tomography (SPECT)imaging
Receives: Drug: [123I]MNI-672 SPECT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects with adverse events

    Safety will be assessed by the number of participants with adverse events.

    Measured: 2 years

  2. Clinically significant changes in vital signs

    Safety will also be assessed by any clinically significant changes in vital signs, ECG parameters, physical examination findings, clinical laboratory findings, and injection site monitoring.

    Measured: 2 years

Secondary outcomes (3)

  1. Total I-123 radioactivity in plasma

    The plasma concentrations will be expressed in %ID/mL. The I-123 radioactivity will be derived from the concentration -time profile.

    Measured: 2 years

  2. Standard uptake values (SUV)

    Standard uptake values (SUV) for the target areas including the frontal cortex, temporal cortex, parietal cortex, posterior cingulate cortex and anterior cingulate cortex, and the cerebellum as the reference region will be calculated. Standard uptake values regional (SUVR) for cortical target areas relative to cerebellum will also be calculated.

    Measured: 2 years

  3. Visual analysis

    The imaging diagnosis will be compared to the clinical diagnosis and Amyvid PET interpretation to determine the efficacy of MNI-672 as a diagnostic tool for AD.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionMar 2015
  4. Study completionApr 2015

Resources

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01859767
Sponsor's protocol ID
MNI-672-01
Status last verified
Dec 2016
First submitted
30 Apr 2013
Last updated
16 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Neary D, Snowden JS, Gustafson L, Passant U, Stuss D, Black S, Freedman M, Kertesz A, Robert PH, Albert M, Boone K, Miller BL, Cummings J, Benson DF. Frontotemporal lobar degeneration: a consensus on clinical diagnostic criteria. Neurology. 1998 Dec;51(6):1546-54. doi: 10.1212/wnl.51.6.1546.

    PubMed 9855500

  • Hughes CP et al: A new clinical scale for staging of dementia. British Journal of Psychiatry 1982; 140: 566-572. Updated by Morris J: The CDR: current version and scoring rules. Neurology 1993; 43: 2412-2413

  • Wahlund LO, Barkhof F, Fazekas F, Bronge L, Augustin M, Sjogren M, Wallin A, Ader H, Leys D, Pantoni L, Pasquier F, Erkinjuntti T, Scheltens P; European Task Force on Age-Related White Matter Changes. A new rating scale for age-related white matter changes applicable to MRI and CT. Stroke. 2001 Jun;32(6):1318-22. doi: 10.1161/01.str.32.6.1318.

    PubMed 11387493

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [123I]MNI-672 SPECT in people with Alzheimer's Disease, 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 0 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 16 Dec 2016. 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?

Number of subjects with adverse events (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01859767, which also lists 3 linked publications.

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 16 Dec 2016.

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