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-ES
• Lead Sponsor: niversity of Geneva

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-11
• Last Update Posted: 20 August 2018

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.
oIn some centres, the patient may receive diagnostic workup before being screened for this study. These patients can be enrolled in the study; however, if they are assigned to the Early Amyloid PET Imaging arm, the results of that workup must not be made available to the managing physician before the managing physician reviews the results of the amyloid PET scan.
•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 (or a legally acceptable representative, for patients with dementia) 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 (neuroinflammatory, neuroinfective, or neurodegenerative disease; multiple sclerosis; genetic disorders; HIV; brain injuries; neurosurgery aftereffects; major depressive episode; schizoaffective disorder; delusional disorder; delirium)
•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. For subjects assigned to the Early Amyloid PET Imaging arm, the managing physician will be blinded to the results of those tests until he or she has reviewed the results of the amyloid PET imaging.
•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.

Study & Design

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