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A preliminary study to test how florbetapir F 18 (18F-AV-45) acts in the brains and bodies of healthy elderly people and patients with Alzheimer's Disease (AD) by using a positron emission tomography (PET) scanner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects With AD | Experimental | Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination (MMSE) from 10 to 24) |
|
| Healthy Elderly Subjects | Experimental | Cognitively normal with MMSE of 29 or higher; age 50 years or older |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| florbetapir F 18 | Drug | IV injection, 370MBq (10mCi), single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Cortical to Cerebellum SUVR | Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the cerebellum gray matter. Total scan length was 200 min. | 50-60 min after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Precuneus to Cerebellum SUVR | Ratio of uptake in the precuneus to uptake in the cerebellum. | 50-60 min after injection |
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Inclusion Criteria (AD group):
Inclusion Criteria (healthy volunteer group):
Exclusion Criteria (both groups):
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Baltimore | Maryland | 21287 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20501908 | Result | Wong DF, Rosenberg PB, Zhou Y, Kumar A, Raymont V, Ravert HT, Dannals RF, Nandi A, Brasic JR, Ye W, Hilton J, Lyketsos C, Kung HF, Joshi AD, Skovronsky DM, Pontecorvo MJ. In vivo imaging of amyloid deposition in Alzheimer disease using the radioligand 18F-AV-45 (florbetapir [corrected] F 18). J Nucl Med. 2010 Jun;51(6):913-20. doi: 10.2967/jnumed.109.069088. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects With AD | Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24) |
| FG001 | Healthy Elderly Subjects | Cognitively normal with MMSE of 29 or higher; age 50 years or older |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects With AD | Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24) |
| BG001 | Healthy Elderly 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 | Mean Cortical to Cerebellum SUVR | Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the cerebellum gray matter. Total scan length was 200 min. | 4 subjects in AD group and 1 subject in the healthy elderly group were excluded due to poor placement and/or excessive movement in the scanner during the 200-minute procedure. | Posted | Mean | Standard Deviation | SUVR | 50-60 min after injection |
|
AEs occuring within 3 days of injection. SAEs occuring within 30 days of injection
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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 | Subjects With AD | Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HEADACHE | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals | 215-298-0700 | clinicaloperations@avidrp.com |
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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 |
|---|---|
| C545186 | florbetapir |
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| North East |
| Maryland |
| 21901 |
| United States |
| Research Site | Long Branch | New Jersey | 07740 | United States |
Cognitively normal with MMSE of 29 or higher; age 50 years or older |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Healthy Elderly Subjects |
Cognitively normal with MMSE of 29 or higher; age 50 years or older |
|
|
| Secondary | Precuneus to Cerebellum SUVR | Ratio of uptake in the precuneus to uptake in the cerebellum. | 4 subjects in AD group and 1 subject in the healthy elderly group were excluded due to poor placement and/or excessive movement in the scanner during the 200-minute procedure. | Posted | Mean | Standard Deviation | SUVR | 50-60 min after injection |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Healthy Elderly Subjects | Cognitively normal with MMSE of 29 or higher; age 50 years or older | 0 | 16 | 2 | 16 |
| CLAUSTROPHOBIA | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |