Diagnostic and Patient Management Study

Phase 1

• Conditions: Alzheimer's diseaseMild Cognitive ImpairmentSubjective Cognitive Decline Plus; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2017-002527-21-NL
• Lead Sponsor: niversity of Geneva

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-20
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 900

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.
oThe patient must be entering a diagnostic assessment for the cognitive complaint.
oThe 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.
oPatients should not have known amyloid status prior to randomization.
•The patient must satisfy the diagnostic criteria for one of the following:
oSCD-Plus
oMCI
oDementia, 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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified