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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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This study is designed to determine the effectiveness of florbetapir (18F) in changing patient management and to evaluate the association between scan status and cognitive decline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results. |
|
| Control | Experimental | Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| florbetapir (18F) | Drug | Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical and Diagnostic Change in Patient Management | Comparison of the percentage of patients who have a change in management from baseline to 3 months for patients who receive scan results immediately (intervention arm) and those who receive scan results 12 months later (control arm). | Baseline and 3 months |
| Change in ADAS-Cog 11 Total Score | Change from baseline in the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) 11 Score in patients with mild impairment by positive or negative florbetapir (18F) PET scan result (Aß+/Aß-). ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 12 month score. A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance. | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient's Clinical Diagnosis | Comparison of the percentage of patients who have a change in diagnosis from baseline to 3 months for patients in the intervention and control arms for whom the scan result was not predicted by the initial diagnosis. | Baseline and 3 months |
| Change in Diagnostic Confidence |
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Inclusion Criteria:
Patients may be enrolled in the mild impairment (not demented) group if the following criteria are met:
Patients may be enrolled in the dementia group if the following criteria are met:
Exclusion Criteria:
Patients will be excluded from enrollment if they:
Patients will also be excluded from enrollment if their enrolling physician:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Phoenix | Arizona | 85006 | United States | ||
| Research Site |
641 patients enrolled in the study. 21 patients withdrew before receiving a florbetapir (F18) PET scan. 620 patients received florbetapir and comprise the Safety Population; 2 patients did not have a valid PET scan. Therefore; 618 patients were randomized to the intervention or control arms and comprise the Efficacy Population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results. florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration |
| FG001 | Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Comparison of the percentage point change in the physician's diagnostic confidence from baseline to month 3 in the intervention and control arms for patients whose scan result was predicted by their baseline clinical diagnosis. Diagnostic confidence was recorded by the physician as a whole number percent from 0-100% and the change in confidence was calculated by subtracting the baseline confidence from the confidence recorded at the specified timepoint. Values greater than zero reflect increased diagnostic confidence; values less than zero reflect decreased diagnostic confidence. |
| Baseline and 3 months |
| Change in Patient Management: Advice/Counseling | Comparison of the percentage of patients in the intervention and control arms who have a change in management relating to advice and counseling from baseline to 3 months. | Baseline and 3 months |
| Change in Caregiver Self-efficacy | Comparison of the change in self-efficacy between intervention and control arms. Change in self-efficacy is defined as the difference between total score on the Fortinsky: Family caregivers' self-efficacy for managing dementia scale at Follow-up (3 months) and baseline. Self-efficacy for managing dementia is defined in terms of specific behaviors or tasks that can be learned, and that are highly relevant to daily management of the disease process. The scale consists of 10 questions, each with responses ranging from 1 (not at all certain) to 10 (very certain). The total score is calculated by summing the response for each item. The total score ranges from 10 to 100, with increasing scores representing increasing caregiver self-efficacy. | Baseline and 3 months |
| Change in Patient Management: Individual Categories | Compare the percentage of patients with a change from baseline in the individual patient management categories at 3 months in the interventional and control arms.The individual categories are: Major diagnostic tests, Alzheimer's/cognition medication, neuropsychological tests, physician follow-up for re-evaluation or specialist referral. | Baseline and 3 months |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Research Site | Scottsdale | Arizona | 85258 | United States |
| Research Site | Sun City | Arizona | 85351 | United States |
| Research Site | Clearwater | Florida | 33756 | United States |
| Research Site | Miami Beach | Florida | 33140 | United States |
| Research Site | Orlando | Florida | 32806 | United States |
| Research Site | West Palm Beach | Florida | 33407 | United States |
| Research Site | Shreveport | Louisiana | 71130 | United States |
| Research Site | Boston | Massachusetts | 02115 | United States |
| Research Site | Chestnut Hill | Massachusetts | 02467 | United States |
| Research Site | Quincy | Massachusetts | 02169 | United States |
| Research Site | Las Vegas | Nevada | 89106 | United States |
| Research Site | Las Vegas | Nevada | 89128 | United States |
| Research Site | Patchogue | New York | 11772 | United States |
| Research Site | Durham | North Carolina | 27710 | United States |
| Research Site | Greensboro | North Carolina | 27405 | United States |
| Research Site | Providence | Rhode Island | 02903 | United States |
| Research Site | Providence | Rhode Island | 02906 | United States |
| Research Site | Salt Lake City | Utah | 84108 | United States |
| Research Site | Bennington | Vermont | 05201 | United States |
| Research Site | Amiens | 80054 | France |
| Research Site | Bordeaux | 33076 | France |
| Research Site | Bron | 69500 | France |
| Research Site | Dijon | 21033 | France |
| Research Site | Lille | 59037 | France |
| Research Site | Marseille | 13385 | France |
| Research Site | Montpellier | 34000 | France |
| Research Site | Nancy | 54035 | France |
| Research Site | Nantes | 44093 | France |
| Research Site | Nice | 06003 | France |
| Research Site | Paris | 75651 | France |
| Research Site | Pessac | 33604 | France |
| Research Site | Reims | 51092 | France |
| Research Site | Rouen | 76031 | France |
| Research Site | Strasbourg | 67098 | France |
| Research Site | Toulouse | 31059 | France |
| Research Site | Tours | 37044 | France |
| Research Site | Villeurbanne | 69100 | France |
| Research Site | Bergamo | 24127 | Italy |
| Research Site | Brescia | 20125 | Italy |
| Research Site | Brescia | 25123 | Italy |
| Research Site | Florence | 50139 | Italy |
| Research Site | Genoa | 16128 | Italy |
| Research Site | Genoa | 16132 | Italy |
| Research Site | Milan | 20122 | Italy |
| Research Site | Milan | 20132 | Italy |
| Research Site | Milan | 20133 | Italy |
| Research Site | Milan | 20162 | Italy |
| Research Site | Modena | 41126 | Italy |
| Research Site | Monza | 20900 | Italy |
| Research Site | Padova | 35128 | Italy |
| Research Site | Parma | 43100 | Italy |
| Research Site | Perugia | 06132 | Italy |
| Research Site | Pisa | 56126 | Italy |
| Research Site | Rome | 00133 | Italy |
| Research Site | Rome | 00179 | Italy |
Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results. florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration |
| BG001 | Control | Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Clinical and Diagnostic Change in Patient Management | Comparison of the percentage of patients who have a change in management from baseline to 3 months for patients who receive scan results immediately (intervention arm) and those who receive scan results 12 months later (control arm). | Analysis population for this endpoint only includes those patients with both a baseline and follow-up value. | Posted | Number | percentage of patients | Baseline and 3 months |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change in ADAS-Cog 11 Total Score | Change from baseline in the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) 11 Score in patients with mild impairment by positive or negative florbetapir (18F) PET scan result (Aß+/Aß-). ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 12 month score. A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance. | Analysis population for this endpoint only includes those patients with mild cognitive impairment, and who reported both a baseline and follow-up value. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 12 months |
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| Secondary | Change in Patient's Clinical Diagnosis | Comparison of the percentage of patients who have a change in diagnosis from baseline to 3 months for patients in the intervention and control arms for whom the scan result was not predicted by the initial diagnosis. | Analysis population for this endpoint only includes those patients whose scan result was not predicted by their baseline clinical diagnosis and recorded both a baseline and follow-up value. | Posted | Number | percentage of patients | Baseline and 3 months |
|
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| Secondary | Change in Diagnostic Confidence | Comparison of the percentage point change in the physician's diagnostic confidence from baseline to month 3 in the intervention and control arms for patients whose scan result was predicted by their baseline clinical diagnosis. Diagnostic confidence was recorded by the physician as a whole number percent from 0-100% and the change in confidence was calculated by subtracting the baseline confidence from the confidence recorded at the specified timepoint. Values greater than zero reflect increased diagnostic confidence; values less than zero reflect decreased diagnostic confidence. | Analysis population for this endpoint only includes those patients whose scan result was predicted by their baseline clinical diagnosis and recorded both a baseline and follow-up value. | Posted | Least Squares Mean | Standard Error | Percentage Point | Baseline and 3 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Patient Management: Advice/Counseling | Comparison of the percentage of patients in the intervention and control arms who have a change in management relating to advice and counseling from baseline to 3 months. | Analysis population for this endpoint only includes those patients with both a baseline and follow-up value. | Posted | Number | percentage of patients | Baseline and 3 months |
|
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| Secondary | Change in Caregiver Self-efficacy | Comparison of the change in self-efficacy between intervention and control arms. Change in self-efficacy is defined as the difference between total score on the Fortinsky: Family caregivers' self-efficacy for managing dementia scale at Follow-up (3 months) and baseline. Self-efficacy for managing dementia is defined in terms of specific behaviors or tasks that can be learned, and that are highly relevant to daily management of the disease process. The scale consists of 10 questions, each with responses ranging from 1 (not at all certain) to 10 (very certain). The total score is calculated by summing the response for each item. The total score ranges from 10 to 100, with increasing scores representing increasing caregiver self-efficacy. | Analysis population for this endpoint only includes those patients with both a baseline and follow-up value. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 3 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Patient Management: Individual Categories | Compare the percentage of patients with a change from baseline in the individual patient management categories at 3 months in the interventional and control arms.The individual categories are: Major diagnostic tests, Alzheimer's/cognition medication, neuropsychological tests, physician follow-up for re-evaluation or specialist referral. | Analysis population for this endpoint only includes those patients with both a baseline and follow-up value. | Posted | Number | percentage of patients | Baseline and 3 months |
|
|
48 hours post-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 | Safety Population | 620 patients received florbetapir (18F) and comprise the Safety Population. | 2 | 620 | 36 | 620 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flushing | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA (18.0) | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (18.0) | Non-systematic Assessment |
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| Feeling abnormal | General disorders | MedDRA (18.0) | Non-systematic Assessment |
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| Malaise | General disorders | MedDRA (18.0) | Non-systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
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| Hallicination, olfactory | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
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| Abnormal faeces | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals | 215-298-0700 | clinicaloperations@avidrp.com |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C545186 | florbetapir |
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| Male |
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| Italy |
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| France |
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