Alzheimer's Disease MedDRA version: 14.1 Level: HLT Classification code 10001897 Term: Alzheimer's disease (incl subtypes) System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Amyvid
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Florbetapir (18 F)
CAS Number: 1205550-99-7
Current Sponsor code: 18F-AV-45
Concentration unit: MBq/ml megabecquerel
Sponsors
AVID RADIOPHARMACEUTICALS, INC.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Dementia group: Are males or females = 50 to =65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
Exclusion criteria: 1. Have a current serious or unstable illness that in the enrolling physician's opinion, could interfere with completion of the safety or efficacy evaluations included in this study, or has a life expectancy of less than one year; 2. The patient or enrolling physician knows the result of a previous amyloid imaging scan; 3. The patient has a known brain lesion, pathology or alternative diagnosis that strongly explains the patient's clinical presentation; 4. Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days; 5. Have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, ? -secretase or ß -secretase inhibitor) unless it can be documented that the patient received only placebo during the course of the trial; 6. Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session; or 7. Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Females of childbearing potential must not be pregnant (negative urine ß-hCG at the time of screening and negative urine ß-hCG on the day of imaging) or breast feeding at screening. Females must avoid becoming pregnant, and must agree to refrain from sexual activity or to use reliable contraceptive methods such as prescribed birth control or IUD for 24 hours following administration of florbetapir (18F).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Patient Management: To evaluate the effectiveness of florbetapir (18F) PET imaging in changing patient management, as defined by the treating physician. Change in management will be determined by comparing the intended management (pre-scan) to the observed management (during the 3 months following the scan). Patient Prognosis: To evaluate the association between scan status and cognitive decline in study patients with mild impairment of cognition as measured by Alzheimer's Disease Assessment Scale —Cognitive subscale (ADAS-cog).;Secondary Objective: The secondary objectives of the study will be to determine whether, at the 3 month timepoint, the scan information leads to (in the interventional arm compared to the control arm): 1. Change in clinical diagnosis in patients for whom the scan result was not predicted by the initial diagnosis (e.g. patients with a clinical diagnosis of AD whose scan result is negative). 2. An increase in diagnostic confidence. 3. An increase in the percentage of patients who have change in management relating to patient and caregiver advice and counseling. 4. Caregiver self-efficacy for managing dementia score. Self-efficacy will be measured by the self-efficacy for managing dementia scale.;Primary end point(s): 1. Patient Management 2. Patient Prognosis;Timepoint(s) of evaluation of this end point: 1. Patient Management - Change in management (a composite of diagnostic testing, treatment and referral, as defined below) will be determined by comparing the intended management (pre-scan) to the observed management (during the 3 months following the scan). 2. Patient Prognosis - hypothesis testing: mildly impaired patients with a positive scan will have significantly greater decline than those with a negative scan after 12 months of follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in clinical diagnosis 2. An increase in diagnostic confidence 3. An increase in the percentage of patients who have change in management relating to patient and caregiver advice and counseling 4. Caregiver self-efficacy for managing dementia score;Timepoint(s) of evaluation of this end point: 1. Change in clinical diagnosis in patients for whom the scan result was not predicted by the initial diagnosis: proportion of patients with scan results that were not predicted by the initial diagnosis and have a change in clinical diagnosis will be greater in the interventional arm compared to the control arm. 2. An increase in diagnostic confidence: comparison of the baseline (pre-scan) confidence to the treating physician's confidence following the scan 3. An increase in the percentage of patients who have change in management relatingto patient and caregiver advice and counseling: during the 3 months following the scan date | — |
Countries
Italy, United States
Contacts
Public ContactMark Lowrey
Avid Radiopharmaceuticals
Outcome results
None listed