Positron emission study of cerebral synaptic density in participants with subjective memory decline

Synaptic modifications in subjective cognitive decline. A study using [18F]UCB-H, a synaptic vesicle 2A radiotracer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002343-29-BE

Enrollment

100

Registered

2020-05-07

Start date

2020-08-11

Completion date

Unknown

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurodegenerative Cognitive Disorder MedDRA version: 21.1 Level: LLT Classification code 10048598 Term: Cognitive disorders System Organ Class: 100000004852

Interventions

Product Name: [18F]UCB-H Product Code: [18F]UCB-H Pharmaceutical Form: Solution for injection CAS Number: 1774352-40-7 Current Sponsor code: [18F]UCB-H Concentration unit: MBq/ml megabecquerel(s)/mill

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy eledrly participants (50 to 90 years old), with and without cognitive complaints, with neuropsychological performance in the normal range. A relative is available to provide information on cognitive functioning of the participant. 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 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 65

Exclusion criteria

Exclusion criteria: Systemic disease, cancer, associated vascular pathology, major psychiatric disease, neurological conditions or medications significantly affecting cognition. Exclusion conditions for MRI.

Design outcomes

Primary

Measure	Time frame
Main Objective: To study cerebral synaptic loss with PET and [18F[UCB-H as a very early marker of neurodegenerative cognitive disorder, according to their brain amyloid load studied with PET and [18F]flutemetamol;Secondary Objective: To compare PET and MRI as early biomarkers of synaptic loss in neurodegenerative cognitive disorder;Primary end point(s): We hypothesize to find negative correlation between the severity of subjective memory complaints and synaptic activity, and a positive correlation between memory test results (withing the range of normality) and synaptic activity in the MTL. Data will be analysed in « amyloid-positive » and « amyloid-negative » participants, and changes over 18 months will be analysed, looking for evolution of synaptic loss according to initial synaptic density and brain amyloid accumulation;Timepoint(s) of evaluation of this end point: (1) Acquisition of data for 50 participants, (2) last inclusion in the trial (T1) and (3) last follow-up visit (T2)	—

Measure

Time frame

Main Objective: To study cerebral synaptic loss with PET and [18F[UCB-H as a very early marker of neurodegenerative cognitive disorder, according to their brain amyloid load studied with PET and [18F]flutemetamol;Secondary Objective: To compare PET and MRI as early biomarkers of synaptic loss in neurodegenerative cognitive disorder;Primary end point(s): We hypothesize to find negative correlation between the severity of subjective memory complaints and synaptic activity, and a positive correlation between memory test results (withing the range of normality) and synaptic activity in the MTL. Data will be analysed in « amyloid-positive » and « amyloid-negative » participants, and changes over 18 months will be analysed, looking for evolution of synaptic loss according to initial synaptic density and brain amyloid accumulation;Timepoint(s) of evaluation of this end point: (1) Acquisition of data for 50 participants, (2) last inclusion in the trial (T1) and (3) last follow-up visit (T2)

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Secondary

Measure	Time frame
Secondary end point(s): As second end point, we will search for a possible influence of MRI measures on the previous relationship, looking for mediation of remote connectivity between MTL and other brain structures (for example in the default mode network) to influence subjective awareness of cognitive decline and possible cognitive performance. ;Timepoint(s) of evaluation of this end point: See primary end point	—

Measure

Time frame

Secondary end point(s): As second end point, we will search for a possible influence of MRI measures on the previous relationship, looking for mediation of remote connectivity between MTL and other brain structures (for example in the default mode network) to influence subjective awareness of cognitive decline and possible cognitive performance. ;Timepoint(s) of evaluation of this end point: See primary end point

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Countries

Belgium

Contacts

Public ContactMedical Director

GIGA-Cyclotron Research Centre ULiege

eric.salmon@uliege.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026