Multicentre, Open-label, Randomised Study to Assess the Diagnostic Value of Amyloid PET Imaging in Patients with Subjective Cognitive Decline Plus, Mild Cognitive Impairment, or Dementia Where Alzheimer*s Disease Is in the Differential Diagnosis (Diagnostic and Patient Management Study)
- Conditions
- amyloidosisdementia1001462310012272
- Registration Number
- NL-OMON50470
- Lead Sponsor
- niversity of Geneva
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 112
* The patient can be of any sex, gender, race, or ethnicity.
* SCD-Plus patients must be 60 to 85 years of age
* Patients with MCI or dementia must be 50 to 85 years of age.
* 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 managing physician must feel that knowledge of amyloid status may
increase diagnostic
confidence or 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
undergone a dementia blood workup or will have one before amyloid PET.
* The patient has an MRI and/or CT scan or will undergo one before amyloid PET.
* 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. In case the patient is randomized to the Early Amyloid PET arm, a
new informed consent should be signed before the second imaging session.
* If the patient has dementia, a study partner is available for the duration of
the protocol.
Patient must be excluded if they meet any one 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 comes to observation for reasons other than diagnosis (disability
assessment for social aids, cognitive assessment for driving license, etc.)
* The patient had a previous A* imaging scan and/or has had other AD biomarker
workup
(fluorodeoxyglucose [FDG]-PET and/or cerebrospinal fluid [CSF] analysis) prior
to screening. In some centres, the patient may receive a diagnostic workup
before screening. These patients can be enrolled if the investigator is blind
to the results until after randomization.
* The patient has a life-threatening or unstable medical disease, or a
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 out 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 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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The difference, at 12 weeks after baseline, between the Early Amyloid PET arm<br /><br>and the Late Amyloid PET arm in the proportion of patients for whom the<br /><br>managing physician has made an etiologic diagnosis with very high confidence<br /><br>(*90%). Diagnostic confidence will be measured with a visual analogue scale<br /><br>(VAS) ranging from 0% (no confidence) to 100% (full confidence).</p><br>
- Secondary Outcome Measures
Name Time Method