Alzheimer DiseasePhase 1/2NCT02149017
Phase 1 and Phase 2 Clinical Trials of SNUBH-NM-333(18F)
A Phase 1/2 study testing SNUBH-NM-333(18F) in people with Alzheimer Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To evaluate pharmacokinetics, safety and efficacy of SNUBH-NM-333(18F), a new diagnostic radiopharmaceutical for PET imaging of amyloid plaques, in Alzheimer's disease patients and healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- SNUBH-NM-333(18F)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2010to Dec 2012
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy young controls who are 20 - 30 years old and have no subjective memrory complaints
- Cognitively normal elderly who have Clinical Dementia Rating score of 0
- Alzheimer's disease (AD) patients who met both the DSM-IV criteria for dementia and NINCDS-ADRDA criteria for probable AD
Who cannot join
- any present serious medical, psychiatric, or neurological disorder that could affect mental function; evidence of focal brain lesions on MRI; the presence of severe behavioral or communication problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 and Phase 2 Clinical Trials for the Evaluation of Pharmacokinetics, Safety, and Efficacy of SNUBH-NM-333(18F) in Alzheimer's Disease Patients and Healthy Volunteers.
To evaluate pharmacokinetics, safety and efficacy of SNUBH-NM-333(18F), a new diagnostic radiopharmaceutical for PET imaging of amyloid plaques, in Alzheimer's disease patients and healthy volunteers.
Read the detailed description
The investigators will perform whole-body and brain kinetic modeling of SNUBH-NM-333(18F) and optimize the image acquisition procedure.
Five young healthy subjects will be participated in Whole-body positron emission tomography /computed tomographic (PET/CT) scans from the midfemoral position to the head after approximately 5-10 mCi of SNUBH-NM-333(18F) injection. For brain PET/CT amyloid imaging, another five young healthy subjects will be scanned dynamically during windows of 0-180 min after injection of SNUBH-NM-333(18F), with arterial sampling.
The investigators will compare different analysis methods of compartmental modeling and standardized uptake value ratios and determine the optimal acquisition window. And then 10 AD patients and 10 elderly healthy controls will also be participated in brain amyloid imaging to compare SNUBH-NM-333(18F) brain retention in AD patients versus healthy elderly.
- Conditions
- Alzheimer Disease
- Being tested
- SNUBH-NM-333(18F)
- Keywords
- amyloid plaque, Positron-Emission Tomography, radiopharmaceuticals
- Medical subject headings
- Alzheimer Disease, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNUBH-NM-333(18F)Radiation
5-10 mCi
| Study group | Role | What they receive |
|---|---|---|
| SNUBH-NM-333(18F), Safety, Efficacy | Experimental | 10 young controls, 10 cognitively normal elderly, and 10 Alzheimer's disease patients Receives: Radiation: SNUBH-NM-333(18F) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution volume ratio (DVR)
DVR = Distribution volume of region of interest/Distribution volume of reference region
Measured: Whole-body positron emission tomography /computed tomographic (PET/CT) scans will be performed within 30 days after screening.
Secondary outcomes (1)
Standardized uptake value ratio (SUVr)
Measured: Whole-body positron emission tomography /computed tomographic (PET/CT) scans will be performed within 30 days after screening.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startDec 2010
- Primary completionMay 2011
- Study completionDec 2012
Why it stopped: SNUH-NM-333 ligand effect was judged to be insufficient.
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.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Inn Woo, Seoul National University Hospital
- Investigators
- Sang Eun Kim, MD, PhD, Study director, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149017
- Sponsor's protocol ID
- SNUBH-NM-333(18F)
- Status last verified
- May 2014
- First submitted
- 19 May 2014
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 and Phase 2 Clinical Trials for the Evaluation of Pharmacokinetics, Safety, and Efficacy of SNUBH-NM-333(18F) in Alzheimer's Disease Patients and Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT02149017
- Acronym / sponsor ID
- SNUBH-NM-333(18F)
- Conditions
- Alzheimer Disease
- Keywords
- amyloid plaque, Positron-Emission Tomography, radiopharmaceuticals
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: SNUH-NM-333 ligand effect was judged to be insufficient.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 May 2014 (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.
To evaluate pharmacokinetics, safety and efficacy of SNUBH-NM-333(18F), a new diagnostic radiopharmaceutical for PET imaging of amyloid plaques, in Alzheimer's disease patients and healthy volunteers.
Detailed description
The investigators will perform whole-body and brain kinetic modeling of SNUBH-NM-333(18F) and optimize the image acquisition procedure.
Five young healthy subjects will be participated in Whole-body positron emission tomography /computed tomographic (PET/CT) scans from the midfemoral position to the head after approximately 5-10 mCi of SNUBH-NM-333(18F) injection. For brain PET/CT amyloid imaging, another five young healthy subjects will be scanned dynamically during windows of 0-180 min after injection of SNUBH-NM-333(18F), with arterial sampling.
The investigators will compare different analysis methods of compartmental modeling and standardized uptake value ratios and determine the optimal acquisition window. And then 10 AD patients and 10 elderly healthy controls will also be participated in brain amyloid imaging to compare SNUBH-NM-333(18F) brain retention in AD patients versus healthy elderly.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SNUBH-NM-333(18F), Safety, Efficacy | Experimental | Radiation: SNUBH-NM-333(18F)10 young controls, 10 cognitively normal elderly, and 10 Alzheimer's disease patients |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy young controls who are 20 - 30 years old and have no subjective memrory complaints
- Cognitively normal elderly who have Clinical Dementia Rating score of 0
- Alzheimer's disease (AD) patients who met both the DSM-IV criteria for dementia and NINCDS-ADRDA criteria for probable AD
Key exclusion criteria (1 listed)
- any present serious medical, psychiatric, or neurological disorder that could affect mental function; evidence of focal brain lesions on MRI; the presence of severe behavioral or communication problems
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 |
|---|---|---|
| SNUBH-NM-333(18F)5-10 mCi | Radiation | SNUBH-NM-333(18F), Safety, Efficacy |
Primary outcome
Distribution volume ratio (DVR)
Time frame: Whole-body positron emission tomography /computed tomographic (PET/CT) scans will be performed within 30 days after screening.
DVR = Distribution volume of region of interest/Distribution volume of reference region
1 secondary outcome
Standardized uptake value ratio (SUVr)
Time frame: Whole-body positron emission tomography /computed tomographic (PET/CT) scans will be performed within 30 days after screening.
Results and safety
The study was stopped early (reason given: SNUH-NM-333 ligand effect was judged to be insufficient.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
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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.
Sang Eun Kim, MD, PhD study director
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SNUBH-NM-333(18F) in people with Alzheimer Disease, run by Seoul National University Hospital at 1 site in South Korea.
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 3 inclusion and 1 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 29 May 2014. 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 South Korea. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: SNUH-NM-333 ligand effect was judged to be insufficient.). 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?
Distribution volume ratio (DVR) (time frame: Whole-body positron emission tomography /computed tomographic (PET/CT) scans will be performed within 30 days after screening.). 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 29 May 2014.