Trials Sponsors Conditions Drugs Pricing

Conditions

Alzheimer's disease

Outcome Measures

Primary Outcomes (1)

F18-MK6240 regional SUVr or spatial extension measure differences between patients and controls

Secondary Outcomes (5)

Associations between F18-MK6240 regional SUVr or spatial extension measures and: Cognitive outcomes - Global cognitive measures - Verbal Episodic Memory - Visuospatial/Constructional - Language - Attention/Executive Functioning - Spatial navigational skills; - Face perception and recognition abilities; Specific semantic memory measures; - Short-term memory binding abilities; - Specific episodic memory processes; - Implicit learning abilities.
Associations between F18-MK6240 regional SUVr or spatial extension measures and CSF biomarker outcomes - Aβ, t-tau, p-tau
Associations between F18-MK6240 regional SUVr or spatial extension measures and Amyloid-PET imaging - Global and regional distribution of amyloid deposition
Associations between F18-MK6240 regional SUVr or spatial extension measures and Neuroimaging outcomes (MRI) - Regional and whole brain volume - Regional cortical thickness - Resting-state functional connectivity - Diffusion-weighted imaging - Task-related brain activity
Associations between F18-MK6240 regional SUVr or spatial extension measures and Blood-derived biomarkers - Amyloid oligomers - Phosphorylated and non-phosphorylated tau species

Interventions

F18-MK6240Type not reported

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Eligibility Criteria

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients with MCI due to AD or mild AD : Age at least 45 years
Able to read and write in French, with a minimum 5 years of formal education

Sponsors & Collaborators

Cliniques Universitaires Saint-Luc
Type not reportedlead

Study Sites (1)

Cliniques Universitaires Saint-Luc

Sint-Lambrechts-Woluwe, 1200, Belgium

Bernard Hanseeuw+3227642270 bernard.hanseeuw@saintluc.uclouvain.be

Central Study Contacts

Bernard Hanseeuw

+3227642270 bernard.hanseeuw@saintluc.uclouvain.be

Study Design

Study Type: interventional
Phase: phase 2 3

Study Record Dates

First Submitted

October 2, 2024

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2024-517074-17-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 05:38:53 UTC

Documents

D1_Protocol_2024-517074-17-00

You may not qualify if:

Presence of any neurological, psychiatric or medical conditions associated with a long-term risk of significant cognitive impairment or dementia including but not limited to pre-manifest Huntington’s disease, multiple sclerosis, active alcohol/drug abuse or major psychiatric disorders including current major depressive disorder, schizophrenia, schizoaffective or bipolar disorder.
Any cancer or history of cancer in the preceding 2 years (excluding cutaneous basal or squamous cell cancer resolved by excision and localized prostate cancer in male subjects)
Any current medical conditions that are clinically significant and might make the subject’s participation in an investigational trial unsafe, e.g., uncontrolled or unstable disease of any major organ system; history within the last 3 months of any acute illness of a major organ system requiring emergency care or hospitalization, including re-vascularization procedures; severe renal or hepatic failure; unstable or poorly controlled diabetes mellitus, hypertension, or heart failure; any clinically relevant abnormalities in blood parameters in routine assessments; severe loss of vision, hearing or communicative ability; or any conditions preventing co-operation or completion of the required assessments in the trial, as judged by the investigator.
Any contraindications for MRI or PET scan
Any evidence of intracranial pathology which, in the opinion of the Investigator, may affect cognition, including but not limited to brain tumors (benign or malignant), aneurysm or arteriovenous malformations, territorial stroke (excluding smaller watershed strokes), recent hemorrhage (parenchymal or subdural), or obstructive hydrocephalus. Participants with a MRI scan demonstrating markers of small vessel disease (e.g. white matter changes or lacunar infarcts) judged to be clinically insignificant, or microbleeds are allowed.
Participation in a clinical trial of an investigational product (IMP) in the 30 days preceding the screening visit. Entering a clinical trial of an investigational product (IMP) is allowed during the current study once the baseline examinations have been performed. The follow-up examinations scheduled in the current study will be proposed to the participants who will have entered a clinical trial during their participation in the current study, depending on the examinations that are scheduled in the clinical trial.
Women of child-bearing potential (WOCBP1, non-menopausal), younger than 55 years old, following any method of contraception not recommended by the Clinical Trial Facilitation Group (CTFG). The use of a highly effective contraception measure should indeed be maintained during any F18 radio-labelled pharmaceutical exposure, until complete F18 decay (meaning at least a minimum period of 18-24 hours after injection).
Pregnancy, or breastfeeding

Tau and Amyloid PET imaging in normal aging, early Alzheimer's disease and related syndroms.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations