Alzheimer's DiseaseEarly Phase 1NCT00954369
Exploratory and Safety Study of [F-18]W372
A Early Phase 1 study testing [F-18]W372 in people with Alzheimer's Disease, run by Siemens Molecular Imaging at 1 site in United States.
Trial summary
PHASE: Phase 0, Exploratory Study OBJECTIVES: To collect drug safety, bio-distribution and dosimetry data, to begin collection of PET/CT imaging data, to acquire experience to improve study design and the conduct of future studies. DESIGN: Exploratory, open label, non-randomized, multi-center study. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- [F-18]W372
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Feb 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
- Low Probability Subjects for AD:
- Subject has reached his or her 55th birthday at the time of the investigational product administration, and is male or female of any race / ethnicity
- Subject or subject's legally acceptable representative provides written informed consent
- Subject is capable of communicating with study personnel
- For inclusion into Group 1, in the opinion of the Investigator, the subject has a low probability of being currently positive for AD that is determined by a Mini Mental State Examination (MMSE ≥ 28)
- High Probability Subjects for AD:
Show all 10Show fewer
- Subject has reached his or her 55th birthday at the time of the investigational product administration, and is male or female of any race / ethnicity
- Subject or subject's legally acceptable representative provides written informed consent
- Subject is capable of communicating with study personnel
- For inclusion into Group 2, in the opinion of the Investigator, the subject has a high probability of being currently positive for AD that is determined by a Mini Mental State Examination (MMSE < 24)
Who cannot join
- For All Subjects:
- Subject is not capable of complying with study procedures
- Female subject is pregnant
- Exclude non-post menopausal females as defined by being one year without menses, or cannot be pregnant from her past medical history
- Subject has prior history of stroke or other condition of the head or neck that, in the Investigator's opinion, might affect circulation to the head or image interpretation
- Subject has a medical condition associated with elevated amyloid levels, such as amyloid angiopathy, familial amyloidosis, chronic kidney dialysis, Down's syndrome
Show all 16Show fewer
- Subject has a history of significant cerebrovascular disease
- Subject has a significant hepatic or renal disease as defined by previous medical history or abnormal hepatic and renal functions determined by lab results not within the following ranges, or, in the opinion of the Investigator, the values are not acceptable for the subject to be included:
- Total bilirubin within 2x institutional upper limits of normal
- AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limits of normal
- Serum creatinine ≤ 2x institutional upper limits of normal
- BUN within 2x institutional upper limits of normal
- Subject has previously received [F-18]W372 at any time
- Subject has been involved in an investigative, radioactive research procedure within the past 14 days
- Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete data or data quality
- Subject has a history in the last five years of significant prescription or nonprescription drug or alcohol abuse, including but not limited to marijuana, cocaine, heroin or derivatives.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Irvine, California, 92697-5020
About this study
Official title: A Phase 0, Open Label, Non-randomized, Multi-center, Exploratory and Safety Study of [F-18]W372
PHASE: Phase 0, Exploratory Study
OBJECTIVES: To collect drug safety, bio-distribution and dosimetry data, to begin collection of PET/CT imaging data, to acquire experience to improve study design and the conduct of future studies.
Read more
DESIGN: Exploratory, open label, non-randomized, multi-center study.
DURATION: Three visits - one screening, one imaging, and one follow-up visit at 24 hours post-dose
PROCEDURES: Informed consent, collection of demographic information and medical history, administration of mental status exam, physical examination, vital signs, 12-lead ECGs, routine blood tests to assess major organ functions, complete blood counts and clinical chemistries for safety, dosing with [F-18]W372, PET imaging scans of brain (in sixteen subjects), whole body PET imaging and urine collections for dosimetry evaluation (in four subjects only), observation and interviews following imaging to collect adverse events.
SUBJECTS: Twenty (20) subjects ≥ 55 years old:
Group 1 will consist of 10 subjects who have a low probability of being currently positive for Alzheimer's Disease (AD) as defined by the protocol criteria (MMSE ≥ 28). Four of the 10 subjects will undergo whole body PET imaging for dosimetry evaluations, and 6 of the 10 subjects will undergo PET imaging of the brain only.
Group 2 will consist of 10 subjects who have a high probability of currently being positive for AD as defined by the protocol criteria (MMSE < 24); these 10 subjects will undergo PET imaging of the brain only.
Read the detailed description
[F-18]W372 is being developed as a diagnostic radiopharmaceutical for PET imaging of the human brain.
SMI is seeking to determine if [F-18]W372 might be useful as a noninvasive assessment tool in aid of clinical evaluations of subjects with conditions associated with increased amyloid-β deposits, such as Alzheimer's disease.
Compared to the other non-invasive imaging approach, the values of amyloid PET imaging are more sensitive and accurate than previously established measures by FDG PET or volumetric MRI for diagnostic classification of subjects, suggesting that amyloid PET ligands may be more useful in differentiating among Alzheimer's disease, mild cognitive impairment, and normal aging as well as other neurodegenerative diseases. Therefore, this novel kind of molecular markers may provide advantages to measure amyloid plaques in vivo, have the potential to revolutionize early diagnosis of Alzheimer's disease, and hopefully will facilitate the AD diagnosis with improved accuracy.
In this exploratory study, the novel PET ligand for imaging amyloid plaques will be evaluated in age-matched normals with low probability being AD and subjects with high probability being AD in order to determine the bio-distribution, visualize signal/background in brains, and ultimately evaluate the safety and feasibility of [F-18] W372 as a potential PET biomarker for imaging amyloids in human brains.
The IP presents no known risks from either in vitro study in cell lines or in vivo study in animals according to preclinical investigations of this compound.
The population to be studied consists of a total of approximately twenty adult subjects, which will be a two group assignment. Group one will consist of ten subjects who have a low probability of being currently positive for Alzheimer's disease (AD) as defined by the protocol criteria. Four of the ten subjects in Group one will undergo evaluations for dosimetry. Group two will consist of ten subjects who have a high probability of currently being positive for AD as defined by the protocol criteria.
In the first year, this exploratory trial will be conducted as a Phase 0 study designed to evaluate bio-distribution data, to collect baseline imaging data, and to gather preliminary safety data for this investigational product. Based on the analyzed study results, this information will be considered in the design of future clinical trials.
The primary objectives of this exploratory study are:
- To collect drug safety information, bio-distribution data, and radiation dosimetry estimation
- To evaluate the drug uptake and signal/background information in brain PET imaging for subjects having a high probability of being currently positive for AD and age-matched subject having a low probability of being currently positive for AD
- To use this exploratory Investigational New Drug (eIND) document in order to obtain the necessary information to file an IND (Investigational New Drug) application with the FDA (Food and Drug Administration)
The secondary objective for this exploratory study is:
- To begin collection of baseline PET imaging data and to gain information to improve the study design for the conduct of future trials
The trial is expected to begin subject enrollment in approximately August 2009 and end subject participation in approximately December 2009, depending on the rate of enrollment.
The subject is expected to attend several visits, adding up to several hours (about 10 hours) of participation over three visits: a screening visit (Visit 1 - about 2 hours), a PET/CT imaging visit (Visit 2 - about 3-4 hours), and a follow up visit (Visit 3 - about 1 hour) about 24 hours after receiving the investigational product.
The investigational product will be administered to each qualified subject via a bolus injection (approximately 10 mCi will be administered for all subjects, except 20 mCi for the four subjects with a low probability of being positive for AD that are involved in the dosimetry analysis). This dose will not exceed 20 mCi, as the imaging time will extend out to approximately three hours. A larger dose (20 mCi) is needed in order to obtain quality images at the later time points.
Each study subject study subject will undergo three (3) visits. Visit 1 will be an initial screening visit to obtain informed consent and to determine if the prospective subject meets inclusion / exclusion criteria by having eligibility blood labs drawn and assessing mental status by performing the Mini-Mental Status Exam (MMSE). Concomitant medications and adverse events are recorded from the time of informed consent through Visit 3. Visit 2 will be an imaging visit in which a physical exam is performed, vital signs are measured, ECG testing is done, and pre-dose blood labs are drawn for safety. The subject then receives one dose of investigational product and undergoes PET imaging. The subject will undergo additional vital sign measurements and ECG testing after dosing during Visit 2. Visit 3 will be done to repeat the drawing of blood labs for safety, measure vital signs, ECG testing is done. All three visits must be completed in order to complete participation in the study.
- Conditions
- Alzheimer's Disease
- Being tested
- [F-18]W372
- Keywords
- Alzheimer's disease, AD, W372, W372000, [F-18]W372, exploratory, imaging
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[F-18]W372Drug
Also called [F-18] W372, W372
The individual doses of [F-18]W372 contain a maximum of 20 mCi for normal volunteers and 10 mCi for high probability AD subjects.
The single IP dose is administered to the study subject immediately prior to the start of PET imaging.
| Study group | Role | What they receive |
|---|---|---|
| [F-18]W372 | Experimental | Approximately twenty (20) adult subjects including ten (10) healthy volunteers and ten (10) high probability AD subjects, as defined by protocol criteria Receives: Drug: [F-18]W372 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety will be the outcome demonstrated in this clinical trial through analyses of adverse events in subjects who receive study drug.
Measured: Three (3) study visits, including the initial screening visit, the imaging visit, and the 24 hour follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siemens Molecular Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lydia Min-Ying Su, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954369
- Sponsor's protocol ID
- W372000
- Status last verified
- Aug 2012
- First submitted
- 5 Aug 2009
- Last updated
- 22 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 0, Open Label, Non-randomized, Multi-center, Exploratory and Safety Study of [F-18]W372
- ClinicalTrials.gov ID
- NCT00954369
- Acronym / sponsor ID
- W372000
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, AD, W372, W372000, [F-18]W372, exploratory, imaging
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Siemens Molecular ImagingIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 7 Aug 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.
PHASE: Phase 0, Exploratory Study
OBJECTIVES: To collect drug safety, bio-distribution and dosimetry data, to begin collection of PET/CT imaging data, to acquire experience to improve study design and the conduct of future studies.
DESIGN: Exploratory, open label, non-randomized, multi-center study.
DURATION: Three visits - one screening, one imaging, and one follow-up visit at 24 hours post-dose
PROCEDURES: Informed consent, collection of demographic information and medical history, administration of mental status exam, physical examination, vital signs, 12-lead ECGs, routine blood tests to assess major organ functions, complete blood counts and clinical chemistries for safety, dosing with [F-18]W372, PET imaging scans of brain (in sixteen subjects), whole body PET imaging and urine collections for dosimetry evaluation (in four subjects only), observation and interviews following imaging to collect adverse events.
SUBJECTS: Twenty (20) subjects ≥ 55 years old:
Group 1 will consist of 10 subjects who have a low probability of being currently positive for Alzheimer's Disease (AD) as defined by the protocol criteria (MMSE ≥ 28). Four of the 10 subjects will undergo whole body PET imaging for dosimetry evaluations, and 6 of the 10 subjects will undergo PET imaging of the brain only.
Group 2 will consist of 10 subjects who have a high probability of currently being positive for AD as defined by the protocol criteria (MMSE < 24); these 10 subjects will undergo PET imaging of the brain only.
Detailed description
[F-18]W372 is being developed as a diagnostic radiopharmaceutical for PET imaging of the human brain.
SMI is seeking to determine if [F-18]W372 might be useful as a noninvasive assessment tool in aid of clinical evaluations of subjects with conditions associated with increased amyloid-β deposits, such as Alzheimer's disease.
Compared to the other non-invasive imaging approach, the values of amyloid PET imaging are more sensitive and accurate than previously established measures by FDG PET or volumetric MRI for diagnostic classification of subjects, suggesting that amyloid PET ligands may be more useful in differentiating among Alzheimer's disease, mild cognitive impairment, and normal aging as well as other neurodegenerative diseases. Therefore, this novel kind of molecular markers may provide advantages to measure amyloid plaques in vivo, have the potential to revolutionize early diagnosis of Alzheimer's disease, and hopefully will facilitate the AD diagnosis with improved accuracy.
In this exploratory study, the novel PET ligand for imaging amyloid plaques will be evaluated in age-matched normals with low probability being AD and subjects with high probability being AD in order to determine the bio-distribution, visualize signal/background in brains, and ultimately evaluate the safety and feasibility of [F-18] W372 as a potential PET biomarker for imaging amyloids in human brains.
The IP presents no known risks from either in vitro study in cell lines or in vivo study in animals according to preclinical investigations of this compound.
The population to be studied consists of a total of approximately twenty adult subjects, which will be a two group assignment. Group one will consist of ten subjects who have a low probability of being currently positive for Alzheimer's disease (AD) as defined by the protocol criteria. Four of the ten subjects in Group one will undergo evaluations for dosimetry. Group two will consist of ten subjects who have a high probability of currently being positive for AD as defined by the protocol criteria.
In the first year, this exploratory trial will be conducted as a Phase 0 study designed to evaluate bio-distribution data, to collect baseline imaging data, and to gather preliminary safety data for this investigational product. Based on the analyzed study results, this information will be considered in the design of future clinical trials.
The primary objectives of this exploratory study are:
- To collect drug safety information, bio-distribution data, and radiation dosimetry estimation
- To evaluate the drug uptake and signal/background information in brain PET imaging for subjects having a high probability of being currently positive for AD and age-matched subject having a low probability of being currently positive for AD
- To use this exploratory Investigational New Drug (eIND) document in order to obtain the necessary information to file an IND (Investigational New Drug) application with the FDA (Food and Drug Administration)
The secondary objective for this exploratory study is:
- To begin collection of baseline PET imaging data and to gain information to improve the study design for the conduct of future trials
The trial is expected to begin subject enrollment in approximately August 2009 and end subject participation in approximately December 2009, depending on the rate of enrollment.
The subject is expected to attend several visits, adding up to several hours (about 10 hours) of participation over three visits: a screening visit (Visit 1 - about 2 hours), a PET/CT imaging visit (Visit 2 - about 3-4 hours), and a follow up visit (Visit 3 - about 1 hour) about 24 hours after receiving the investigational product.
The investigational product will be administered to each qualified subject via a bolus injection (approximately 10 mCi will be administered for all subjects, except 20 mCi for the four subjects with a low probability of being positive for AD that are involved in the dosimetry analysis). This dose will not exceed 20 mCi, as the imaging time will extend out to approximately three hours. A larger dose (20 mCi) is needed in order to obtain quality images at the later time points.
Each study subject study subject will undergo three (3) visits. Visit 1 will be an initial screening visit to obtain informed consent and to determine if the prospective subject meets inclusion / exclusion criteria by having eligibility blood labs drawn and assessing mental status by performing the Mini-Mental Status Exam (MMSE). Concomitant medications and adverse events are recorded from the time of informed consent through Visit 3. Visit 2 will be an imaging visit in which a physical exam is performed, vital signs are measured, ECG testing is done, and pre-dose blood labs are drawn for safety. The subject then receives one dose of investigational product and undergoes PET imaging. The subject will undergo additional vital sign measurements and ECG testing after dosing during Visit 2. Visit 3 will be done to repeat the drawing of blood labs for safety, measure vital signs, ECG testing is done. All three visits must be completed in order to complete participation in the study.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [F-18]W372 | Experimental | Drug: [F-18]W372Approximately twenty (20) adult subjects including ten (10) healthy volunteers and ten (10) high probability AD subjects, as defined by protocol criteria |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject has reached his or her 55th birthday at the time of the investigational product administration, and is male or female of any race / ethnicity
- Subject or subject's legally acceptable representative provides written informed consent
- Subject is capable of communicating with study personnel
- For inclusion into Group 1, in the opinion of the Investigator, the subject has a low probability of being currently positive for AD that is determined by a Mini Mental State Examination (MMSE ≥ 28)
- Subject has reached his or her 55th birthday at the time of the investigational product administration, and is male or female of any race / ethnicity
Key exclusion criteria (16 listed)
- Subject is not capable of complying with study procedures
- Female subject is pregnant
- Subject has prior history of stroke or other condition of the head or neck that, in the Investigator's opinion, might affect circulation to the head or image interpretation
- Subject has a medical condition associated with elevated amyloid levels, such as amyloid angiopathy, familial amyloidosis, chronic kidney dialysis, Down's syndrome
- Subject has a history of significant cerebrovascular disease
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 |
|---|---|---|
| [F-18]W372Also: [F-18] W372, W372The individual doses of [F-18]W372 contain a maximum of 20 mCi for normal volunteers and 10 mCi for high probability AD subjects. The single IP dose is administered to the study subject immediately prior to the start of PET imaging. | Drug | [F-18]W372 |
Primary outcome
Safety will be the outcome demonstrated in this clinical trial through analyses of adverse events in subjects who receive study drug.
Time frame: Three (3) study visits, including the initial screening visit, the imaging visit, and the 24 hour follow-up visit
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 22 Aug 2012.
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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.
Lydia Min-Ying Su, PhD principal investigator
University of California, Irvine
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 [F-18]W372 in people with Alzheimer's Disease, run by Siemens Molecular Imaging 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 10 inclusion and 16 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 22 Aug 2012. 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?
Safety will be the outcome demonstrated in this clinical trial through analyses of adverse events in subjects who receive study drug. (time frame: Three (3) study visits, including the initial screening visit, the imaging visit, and the 24 hour follow-up visit). 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 22 Aug 2012.