Alzheimer Disease
Conditions
Keywords
Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging
Brief summary
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.
Interventions
DRUGflorbetapir F 18
IV injection, 370MBq (10mCi), single dose
Sponsors
Avid Radiopharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
(AD group): * Probable AD according to the National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria * Mild/moderate dementia as evidenced by a mini mental state exam (MMSE) score ranging from 10 to 24, boundaries included, at screening * History of cognitive decline had been gradual in onset and progressive over a period of at least 6 months Inclusion Criteria (healthy volunteer group): * No evidence of significant cognitive impairment by history and psychometric testing * MMSE of 29 or higher
Exclusion criteria
(both groups): * Neurodegenerative disorders other than AD * Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation * Clinically significant infarct or possible multi-infarct dementia as defined by the NINCDS criteria * Evidence on screening MRI or other biomarker that suggests alternate etiology for cognitive deficit (for healthy controls, evidence suggesting the presence of AD pathology) * Clinically significant psychiatric disease * History of epilepsy or convulsions * Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances * Current clinically significant cardiovascular disease * Received investigational medication within the last 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Cortical to Cerebellum SUVR | 50-60 min after injection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Precuneus to Cerebellum SUVR | 50-60 min after injection | Ratio of uptake in the precuneus to uptake in the cerebellum. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 16 |
| Healthy Elderly Subjects Cognitively normal with MMSE of 29 or higher; age 50 years or older | 16 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Subjects With AD | Healthy Elderly Subjects | Total |
|---|---|---|---|
| Age Continuous | 75.8 years STANDARD_DEVIATION 9.2 | 72.5 years STANDARD_DEVIATION 11.56 | 74.3 years STANDARD_DEVIATION 10.44 |
| Region of Enrollment United States | 16 participants | 16 participants | 32 participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 14 Participants |
| Sex: Female, Male Male | 8 Participants | 10 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 2 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
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.
Time frame: 50-60 min after injection
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects With AD | Mean Cortical to Cerebellum SUVR | 1.665 SUVR | Standard Deviation 0.175 |
| Healthy Elderly Subjects | Mean Cortical to Cerebellum SUVR | 1.246 SUVR | Standard Deviation 0.177 |
Secondary
Precuneus to Cerebellum SUVR
Ratio of uptake in the precuneus to uptake in the cerebellum.
Time frame: 50-60 min after injection
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects With AD | Precuneus to Cerebellum SUVR | 1.847 SUVR | Standard Deviation 0.237 |
| Healthy Elderly Subjects | Precuneus to Cerebellum SUVR | 1.300 SUVR | Standard Deviation 0.271 |