Alzheimer's disease Mild Cognitive Impairment Subjective Cognitive Decline Plus
Conditions
Interventions
Trade Name: Neuraceq
Product Name: Neuraceq
Pharmaceutical Form: Solution for injection
Trade Name: Vizamyl
Pharmaceutical Form: Solution for injection
Sponsors
University of Geneva
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • The patient can be male or female and of any race or ethnicity. • The patient must be 60 to 85 years of age (for patients with SCD-Plus) or 50 to 85 years of age (for patients with MCI or with dementia where AD is in the differential diagnosis). • The patient must have a complaint (reported by the patient or by a caregiver) of cognitive problems that are considered by the managing physician to be possibly due to AD. o The patient must be entering a diagnostic assessment for the cognitive complaint. o The patient’s managing physician at the memory clinic must feel that knowledge of the patient’s brain amyloid status may increase diagnostic confidence and alter diagnosis and management. o Patients should not have known amyloid status prior to randomization. • The patient must satisfy the diagnostic criteria for one of the following: o SCD-Plus o MCI o Dementia, where AD is in the differential diagnosis • The patient has an MRI and/or CT scan that excludes an intracranial mass or other lesion(s) that could explain cognitive impairment. • The patient can complete all clinical visits according to the protocol. • The patient can tolerate a 20-minute amyloid PET scan. • The patient provides informed consent for study participation and data source verification. • If the patient has dementia, he or she has a study partner willing and able to accompany him or her to all visits for the duration of the protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 650
Exclusion criteria
Exclusion criteria: Subjects must be excluded from participating in this study if they meet any of the following criteria: • The patient has another confirmed condition that can fully account for the cognitive impairment, including but not limited to psychiatric disorders (schizophrenia, mood disorders, bipolar disorder and personality disorders; neuroinflammatory, neuroinfective, or neurodegenerative diseases; multiple sclerosis; genetic disorders; HIV; brain injuries; neurosurgery aftereffects; major depressive episode; schizoaffective disorder; delusional disorder; delirium). Patients with long-known, stabilized psychiatric or other brain conditions that cannot fully account for the cognitive impairment may be included in the study. • The patient came to observation of the memory clinic for reasons other than diagnosis (disability assessment for social aids, cognitive assessment for driving license, etc.) • The patient had a previous beta-amyloid imaging scan and/or has had other diagnostic workup (fluorodeoxyglucose [FDG]-PET and/or cerebrospinal fluid [CSF] analysis) for a cognitive complaint prior to the screening. (In some centres, the patient may receive a diagnostic workup before the screening for this study. These patients can be enrolled in the study only if the investigator is blinded to the results of those tests until after randomization. • The patient has any life-threatening unstable medical disease or psychiatric condition that could lead to difficulty in complying with the protocol. • The patient is currently receiving an investigational pharmaceutical product or has participated in a clinical trial with an investigational pharmaceutical product within 30 days prior to screening, and/or was administered a radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study. • The patient is a woman who is pregnant, planning to become pregnant, or lactating. Pregnancy status of a woman with childbearing potential will be carried outchecked before the PET scan. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile (www.hma.eu/ctfg.html, Recommendations related to contraception and pregnancy testing in clinical trials, September 2014). • The patient is employed at the research department or memory clinic, is directly involved with the study, or is not a family relative from any department personnel (i.e. partner, older child, sibling, biological or legal representative). • Any of the contraindications as registered for the study drug used is applicable to the subject. Any of the warnings or precautions as registered for the IMP used is applicable to the subject, unless a risk-benefit assessment is favorable as per the judgement of the sponsor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that the proportion of subjects for whom the managing physician reaches an aetiologic diagnosis with very high confidence (=90%) at 12 weeks after baseline is higher for subjects who underwent amyloid PET imaging shortly after baseline than for subjects who have not yet undergone amyloid PET imaging (ie, subjects scheduled to undergo amyloid PET imaging at 8 months [±8 weeks] after baseline).;Secondary Objective: 1) To assess the impact of amyloid PET imaging on Diagnosis and confidence (Time to communicate to the patient an aetiologic diagnosis with very high confidence (=90%); Changes in the managing physician’s aetiologic diagnosis and diagnostic confidence over time; and the managing physician’s estimate of the likelihood that the patient’s symptoms are due to AD. 2) To assess the impact of amyloid PET imaging on diagnostic and patient management, including: change or early adoption of programs and pharmacologic treatments aimed to delay the onset or progression of cognitive impairment; and Use of medical resources. 3) To assess the impact of amyloid PET imaging on: • Patient-related outcomes (cognition, anxiety, depression, coping skills, and quality of life) • Cost of diagnostic workup to the aetiologic diagnosis with very high confidence (=90%) • Number of patients who are discharged from the memory centre and the reason for discharge 4) Imaging results assessment ;Primary end point(s): The difference, at 12 weeks after baseline, between the Early Amyloid PET Imaging arm and the Late Amyloid PET Imaging arm in the proportion of patients for whom the managing physician has made an aetiologic diagnosis with very high confidence (=90%). Diagnostic confidence, which is the managing physician’s confidence that the diagnosis is correct, will be measured with a visual analogue scale (VAS) from 0% (no confidence) to 100% (full confidence).;Timepoint(s) of evaluation of this end point: At 12 weeks after Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Diagnosis and Confidence • The difference between the Early Amyloid PET Imaging arm and the Late Amyloid PET Imaging arm in the time (from baseline) to communicate to the patient an aetiologic diagnosis with very high confidence (=90%). • Change of etiologic diagnosis and incremental diagnostic confidence between Baseline visit (T0) and T1 in each arm. • ‘The changes in the managing physician’s aetiologic diagnosis at T3 vs T2 vs T1 in each arm. • The changes in the managing physician’s diagnostic confidence at T3 vs T2 vs T1 vs T0 in the Early Amyloid PET Imaging arm vs the Late Amyloid PET Imaging arm. • The managing physician’s estimate of the likelihood that the patient’s symptoms are due to AD at T3 vs T2 vs T1 vs T0 in the Early Amyloid PET Imaging arm vs the Late Amyloid PET Imaging arm. • Changes over calendar time in the placement of amyloid PET imaging in the patient workup for subjects in the Free Choice Amyloid PET Imaging arm. Patient Management • The difference between arms (Early Amyloid PET Imaging arm, the Late Amyloid PET Imaging arm, or the Free Choice Amyloid PET Imaging arm) in the number of patients randomised to disease-modifying drug (DMD) or any other AD clinical trial at T2. • The difference between the Early Amyloid PET Imaging arm and the Late Amyloid PET Imaging arm in number of subjects with changes in the management plan (changes in or start of a new program or pharmacologic treatment) at T1 vs T2 vs T3. • Health Economics and Outcomes Research (HEOR) The impact on patient-related outcomes (cognition, anxiety, depression, coping skills, and quality of life) at T3 vs T2 vs T0 in each arm • The difference in the cost of diagnostic workup to the aetiologic diagnosis with very high confidence (=90%) in the Early Amyloid PET Imaging arm vs the Late Amyloid PET Imaging arm. (In those centres where the subjects in the Early Amyloid PET Imaging arm receive a diagnostic workup in addition to clinical evaluation b | — |
Countries
France, Germany, Netherlands, Spain, Sweden, Switzerland, United Kingdom
Contacts
Public ContactLANVIE
University of Geneva
Outcome results
None listed