Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will test if two flortaucipir PET scans up to 4 weeks apart in healthy volunteers, MCI and AD subjects provide the same results.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteer Subjects | Experimental | Healthy males or females 50 years or older with no evidence of cognitive impairment |
|
| MCI subjects | Experimental | Subjects 50 years or older with mild cognitive impairment (MCI) |
|
| Probable AD Subjects | Experimental | Subjects 50 years or older with probable Alzheimer's Disease (AD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flortaucipir F18 | Drug | IV injection, 370 MBq (10 mCi), two doses up to four weeks apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Test-Retest Reproducibility | Evaluate test-retest reproducibility of flortaucipir for brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVRs) for each scan, normalized to the cerebellar crus. A combination volume of interest (VOI) = weighted average of parietal, temporal, and occipital regions was used. The protocol pre-specified that test-retest endpoint was to be calculated for the combined group of healthy volunteers and cognitively impaired subjects | 80-100 minutes postdose |
| Test-Retest Reproducibility | Evaluate test-retest reproducibility of 18F-AV-1451 for brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVRs) for each scan, normalized to the cerebellar crus. A combination volume of interest (VOI) = weighted average of parietal, temporal, and occipital regions was used. The protocol pre-specified that test-retest endpoint was to be calculated for the combined group of healthy volunteers and cognitively impaired subjects | 110-130 minutes postdose |
Not provided
Not provided
Inclusion Criteria:
Healthy Volunteers
MCI Subjects
Probable AD Subjects
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Newport Beach | California | 92663 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29284675 | Result | Devous MD Sr, Joshi AD, Navitsky M, Southekal S, Pontecorvo MJ, Shen H, Lu M, Shankle WR, Seibyl JP, Marek K, Mintun MA. Test-Retest Reproducibility for the Tau PET Imaging Agent Flortaucipir F 18. J Nucl Med. 2018 Jun;59(6):937-943. doi: 10.2967/jnumed.117.200691. Epub 2017 Dec 28. |
Not provided
Not provided
Not provided
Enrollment between Nov 2013 and May 2014
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Volunteer Subjects | Healthy males or females 50 years or older with no evidence of cognitive impairment Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart Brain PET scan: positron emission tomography (PET) scan of the brain |
| FG001 | MCI Subjects | Subjects 50 years or older with mild cognitive impairment (MCI) Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart Brain PET scan: positron emission tomography (PET) scan of the brain |
| FG002 | Probable AD Subjects | Subjects 50 years or older with probable Alzheimer's Disease (AD) Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart Brain PET scan: positron emission tomography (PET) scan of the brain |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Volunteer Subjects | Healthy males or females 50 years or older with no evidence of cognitive impairment Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart Brain PET scan: positron emission tomography (PET) scan of the brain |
| BG001 | MCI Subjects |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Test-Retest Reproducibility | Evaluate test-retest reproducibility of flortaucipir for brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVRs) for each scan, normalized to the cerebellar crus. A combination volume of interest (VOI) = weighted average of parietal, temporal, and occipital regions was used. The protocol pre-specified that test-retest endpoint was to be calculated for the combined group of healthy volunteers and cognitively impaired subjects | All subjects with a valid test and re-test scan. The 80-100 minute scan was not done for one subject in the healthy volunteer group due to technical difficulties with the scanning apparatus | Posted | Mean | Standard Deviation | standardized uptake value ratio (SUVr) | 80-100 minutes postdose |
|
End of study for AE reporting was 48 hours after flortaucipir administration at each imaging visit.
Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection, at an imaging visit. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to flortaucipir.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Volunteer Subjects | Healthy males or females 50 years or older with no evidence of cognitive impairment Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart Brain PET scan: positron emission tomography (PET) scan of the brain |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dysgeusia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Avid Radiopharmaceuticals, Inc. | 215-298-0700 | clinicaloperations@avidrp.com |
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591008 | 7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Brain PET scan | Procedure | positron emission tomography (PET) scan of the brain at 80-100 and 110-130 minutes after injection |
|
| New Haven |
| Connecticut |
| 06510 |
| United States |
Subjects 50 years or older with mild cognitive impairment (MCI) Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart Brain PET scan: positron emission tomography (PET) scan of the brain |
| BG002 | Probable AD Subjects | Subjects 50 years or older with probable Alzheimer's Disease (AD) Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart Brain PET scan: positron emission tomography (PET) scan of the brain |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Mini Mental Status Exam (MMSE) | Mini-mental status exam (MMSE) is a 30-point questionnaire that is used to measure cognitive impairment. Scores range from 0 to 30 with lower scores representing greater levels of cognitive impairment. | Mean | Standard Deviation | units on a scale |
|
|
|
|
| Primary | Test-Retest Reproducibility | Evaluate test-retest reproducibility of 18F-AV-1451 for brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVRs) for each scan, normalized to the cerebellar crus. A combination volume of interest (VOI) = weighted average of parietal, temporal, and occipital regions was used. The protocol pre-specified that test-retest endpoint was to be calculated for the combined group of healthy volunteers and cognitively impaired subjects | Posted | Mean | Standard Deviation | standardized uptake value ratio (SUVr) | 110-130 minutes postdose |
|
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | MCI Subjects | Subjects 50 years or older with mild cognitive impairment (MCI) Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart Brain PET scan: positron emission tomography (PET) scan of the brain | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Probable AD Subjects | Subjects 50 years or older with probable Alzheimer's Disease (AD) Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart Brain PET scan: positron emission tomography (PET) scan of the brain | 0 | 10 | 0 | 10 | 3 | 10 |
| diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| hypertension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
Not provided
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |