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The intent of this research protocol is to test the equivalency of two amyloid imaging drugs (C11 Pittsburgh Compound B and F18 Flutemetamol). The investigators hypothesize that there will be no significant difference in the distribution of the agents to areas of amyloid deposition in the brain or to other normal brain structures. Recent data have shown similarity in the distribution of the drugs in subjects with Alzheimer's disease (AD) or mild cognitive impairment (MCI). No comparison data of the two PET drugs in normal subjects has been published. It is important to understand differences in the images and biodistribution from the two drugs in normal subjects as nonspecific accumulation of the drugs in brain structures such as white matter appear to differ slightly and could affect image performance.
Some of the current thinking in regards to the pathophysiology of AD involves the production of amyloid Beta protein (AB) by secretase processing of amyloid precursor protein (APP). While AB is thought to be toxic to neurons its role leading to AD pathogenesis, this is not without debate. In any case, it appears that AB forms amyloid plaques that are largely ubiquitous in AD. Neuronal cell death as a result of the disease is another clear pathophysiologic finding. Because of the importance of these findings in the development of AD, targeted therapies are being investigated to selectively inhibit AB production and/or manipulate amyloid load.
Positron emission tomography (PET) is a molecular imaging modality used to noninvasively measure functional processes of the body. A trace amount of a radiopharmaceutical is injected into a patient and the radiopharmaceutical will be taken up or localized in the body as a function of certain biological processes. The detectors of a PET scanner then measure the radiopharmaceutical distribution externally and the reconstructed PET images should represent the true distribution of the radiopharmaceutical within the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alzheimer's Disease | Experimental | Subjects who have the clinical diagnosis of probable AD ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR). Interventions include C11 PiB PET/CT and F-18 Flutametamol PET/CT with C11 PiB PET/CT performed first. |
|
| Cognitive Normal Elderly | Active Comparator | Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT and F-18 Flutametamol PET/CT with C11 PiB PET/CT performed first. |
|
| Cognitive Normal Young | Active Comparator | Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT and F-18 Flutametamol PET/CT with C11 PiB PET/CT performed first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C11 PiB | Drug | One time intravenous administration of 8-22 millicurie (mCi) C11 PiB |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global Distribution of C11 PiB in the Brain | The imaging analysts use a global atlas of the brain to measure the uptake of the radioactive tracer (or brightness) globally. This global uptake was normalized to the uptake in the cerebellar crus region of the brain to get a global Standard Uptake Value Ratio (SUVR). The cerebral crus (crus cerebri) is the anterior portion of the cerebral peduncle which contains the motor tracts. The standard uptake value (SUV) is a way of determining activity in PET imaging. The SUVR is the ratio of SUV from two different regions within the same PET image. For the SUVR, the injected activity, the body weight and the volume to mass conversion factor that are all part of the SUV calculation, cancel. | Approximately one hour after injection of positron emission tomography (PET) drug |
| Global Distribution of F18 Flutemetamol in the Brain | The imaging analysts use a global atlas of the brain to measure the uptake of the radioactive tracer (or brightness) globally. This global uptake was normalized to the uptake in the cerebellar crus region of the brain to get a global Standard Uptake Value Ratio (SUVR). The cerebral crus (crus cerebri) is the anterior portion of the cerebral peduncle which contains the motor tracts. The standard uptake value (SUV) is a way of determining activity in PET imaging. The SUVR is the ratio of SUV from two different regions within the same PET image. For the SUVR, the injected activity, the body weight and the volume to mass conversion factor that are all part of the SUV calculation, cancel. | Approximately one hour after injection of positron emission tomography (PET) drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Val Lowe, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
This study was funded by an industrial partner (GE) and discussions with the company about sharing the data will be entertained after first publications.
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89 subjects were consented, but 1 subject was a screen failure prior to assignment.
Participants were recruited from Mayo Clinic in Minnesota.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alzheimer's Disease | Subjects who have the clinical diagnosis of probable Alzheimer's disease (AD) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR). Interventions include C11 Pittsburgh Compound B (PiB) PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 millicurie (mCi) C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol. |
| FG001 | Cognitive Normal Elderly | Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol. |
| FG002 | Cognitive Normal Young | Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alzheimer's Disease | Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR). Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Global Distribution of C11 PiB in the Brain | The imaging analysts use a global atlas of the brain to measure the uptake of the radioactive tracer (or brightness) globally. This global uptake was normalized to the uptake in the cerebellar crus region of the brain to get a global Standard Uptake Value Ratio (SUVR). The cerebral crus (crus cerebri) is the anterior portion of the cerebral peduncle which contains the motor tracts. The standard uptake value (SUV) is a way of determining activity in PET imaging. The SUVR is the ratio of SUV from two different regions within the same PET image. For the SUVR, the injected activity, the body weight and the volume to mass conversion factor that are all part of the SUV calculation, cancel. | Posted | Mean | Standard Deviation | standard uptake value ratio | Approximately one hour after injection of positron emission tomography (PET) drug |
|
Participants were followed for adverse events over the 24 hour period after injection with the study drugs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alzheimer's Disease | Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR). Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased vision | Eye disorders | Systematic Assessment | Event experienced while subjects were on C-11 PIB, determined to be unrelated to study drug |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Val Lowe | Mayo Clinic | 507-255-3616 | vlowe@mayo.edu |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C475519 | 2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole |
| C581552 | flutemetamol |
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|
| F18 Flutametamol | Drug | One time intravenous administration of 3-7 mCi F18 Flutametamol. |
|
|
| BG001 | Cognitive Normal Elderly | Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol. |
| BG002 | Cognitive Normal Young | Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Cognitive Normal Elderly | Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol. |
| OG002 | Cognitive Normal Young | Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol. |
|
|
|
| Primary | Global Distribution of F18 Flutemetamol in the Brain | The imaging analysts use a global atlas of the brain to measure the uptake of the radioactive tracer (or brightness) globally. This global uptake was normalized to the uptake in the cerebellar crus region of the brain to get a global Standard Uptake Value Ratio (SUVR). The cerebral crus (crus cerebri) is the anterior portion of the cerebral peduncle which contains the motor tracts. The standard uptake value (SUV) is a way of determining activity in PET imaging. The SUVR is the ratio of SUV from two different regions within the same PET image. For the SUVR, the injected activity, the body weight and the volume to mass conversion factor that are all part of the SUV calculation, cancel. | Posted | Mean | Standard Deviation | standard uptake value ratio | Approximately one hour after injection of positron emission tomography (PET) drug |
|
|
|
|
| 0 |
| 24 |
| 1 |
| 24 |
| EG001 | Cognitive Normal Elderly | Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol. | 0 | 30 | 4 | 30 |
| EG002 | Cognitive Normal Young | Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT. C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol. | 0 | 30 | 2 | 30 |
|
| Hypoglycemia | Gastrointestinal disorders | Systematic Assessment | Event experienced while subject on F-18 Flutemetamol, determined to be unrelated to study drug. |
|
| Heart palpitations (moderate) | Cardiac disorders | Systematic Assessment | Event experienced while subject on F-18 Flutemetamol, determined to be unrelated to study drug. |
|
| Metallic taste | Gastrointestinal disorders | Systematic Assessment | Event experienced while subject was on F-18 Flutemetamol, determined to be not related to study drug. |
|
| Leg cramp (mild) | Musculoskeletal and connective tissue disorders | Systematic Assessment | Event experienced while subject was on F-18 Flutemetamol, determined to be unrelated to study drug. |
|
| Dizziness (mild) | Nervous system disorders | Systematic Assessment | Event experienced while subject was on F-18 Flutemetamol, determined to be unrelated to study drug. |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Superiority or Other |
| t-test, 2 sided | <0.001 | Superiority or Other |