Study by mean of brain positron emission tomography (PET) of a tracer specific for inflammation [[18F]GE-180, or 18FGEH120714] in patients affected by cognitive impairment

SINGLE ARM, OPEN-LABEL, UNCONTROLLED PHASE II PILOT STUDY ON BRAIN PET WITH THE TRACER [18F]GE-180 (18FGEH120714) IN PATIENTS AFFECTED BY COGNITIVE DECLINE - GE-180-01

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003878-41-IT

Enrollment

Registered

2021-06-08

Start date

2016-12-09

Completion date

Unknown

Last updated

2025-02-10

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

Conditions

Patients affected by degenerative MedDRA version: 21.1 Level: LLT Classification code 10009843 Term: Cognitive deterioration System Organ Class: 100000004852

Interventions

Pharmaceutical Form: Solution for infusion INN or Proposed INN: [18F]GEH120714 Current Sponsor code: [18F]GEH120714 Concentration unit: MBq/ml megabecquerel(s)/millilitre Concentration type: equal Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients of both sexes, aged between 60 and 80 years; patients must be able to understand the protocol and to express a valid signed informed consent. Patients must have a relative or friend spending with them at least 10 hours/week (caregiver). Female patients must have been in menopause for at least twelve months before being included in the study. Patients must have a diagnosis of dementia due to AD probable according to National Institute on Aging–Alzheimer's Association – 2011 (NIA-AA) criteria and a CDR: 0,5-1 and raw MMSE score> 16; or a diagnosis of MCIa according to National Institute on Aging–Alzheimer's Association – 2011 (NIA-AA) criteria; or a diagnosis of fronto-temporal dementia probable (according to criteria by Neary et al., 1998, and Rascowsky et al., 2011), or a diagnosis of Parkinson's Disease Dementia (according to criteria by Emre et al.2007) or a diagnosis of Lewy Body Dementia probable (according to criteria by McKeith et al. 2005). Patients will have been submitted to an MRI in the previous 6 months, during their diagnostic work up. 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 2 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: Patients with a psychiatric illness diagnosis (Axis 1 or 2 of DSM IV, schizophrenia, bipolar disorder, uncontrolled major depression) and neurological disorders potentially causing/concurring to the cognitive complaints in researcher’s judgment. Patients with cognitive disorders secondary to concomitant medical conditions . Patients participating to clinical trials involving AD disease-modifying treatments, registered on ClicalTrials.gov. Patients treated with NSAIDs or cortisone-based drugs orally or e.v. in the 28 days preceding PET exam. Alcohol or Substance abusers. Patients not able to express valid consent. Patients with moderate/severe cerebrovascular disease (according to modified Fazekas score). Patients with physical/medical conditions contraindicating venous access positioning. Patients with severe infective comorbidities such as sepsis, pneumonia, within 30 days of enrollment, or previous meningoencephalitis. Patients with severe medical or cardiologic comorbidities.

Design outcomes

Primary

Measure	Time frame
Main Objective: ¿To evaluate whether there are differences in the brain distribution of the neuroinflammation marker [18F]GE-180 in the brain of patients affected by AD dementia, as compared with patients affected by MCIa converting in dementia at follow up, and patients with MCIa non converting to dementia at follow-up.;Secondary Objective: ¿To correlate the brain distribution of the neuroinflammation marker [18F]GE-180 in single patients with a brain RMN marker of the noradrenergic brain nucleus Locus Coeruleus assessed on MRI previously performed in the same patients ¿To evaluate whether there are differences in the brain distribution of the neuroinflammation marker [18F]GE-180 in the brain of patients affected by AD dementia as compared with patients affected by fronto-temporal dementia, Parkinson's Disease Dementy and Lewy Body Dementia ¿To evaluate whether there are differences in the brain distribution of the neuroinflammation marker [18F]GE-180 within the groups AD dementia, MCIa converters and MCIa non converters, which are related to the severity clinical features and disease duration of patients ¿To evaluate whether there are differences in the brain distribution of the neuroinflammation marker [18F]GE-180 between the groups of MCIa converters and MCIa non converters ;Primary end point(s): Evaluation of differences in the brain distribution of the neuroinflammation marker [18F]GE-180 in the brain of patients affected by AD dementia, as compared with patients affected by MCIa converting in dementia at follow up, and patients with MCIa non converting to dementia at follow-up.;Timepoint(s) of evaluation of this end point: At 16th months from study start a first interim analysis will be performed to assess data in patients recruited up to this time point and reevaluate whether primary end-point will be achieved with a number of patients lower than expected. A final analysis will be performed at 36 months after enrollment of first patient	—

Measure

Time frame

Main Objective: ¿To evaluate whether there are differences in the brain distribution of the neuroinflammation marker [18F]GE-180 in the brain of patients affected by AD dementia, as compared with patients affected by MCIa converting in dementia at follow up, and patients with MCIa non converting to dementia at follow-up.;Secondary Objective: ¿To correlate the brain distribution of the neuroinflammation marker [18F]GE-180 in single patients with a brain RMN marker of the noradrenergic brain nucleus Locus Coeruleus assessed on MRI previously performed in the same patients ¿To evaluate whether there are differences in the brain distribution of the neuroinflammation marker [18F]GE-180 in the brain of patients affected by AD dementia as compared with patients affected by fronto-temporal dementia, Parkinson's Disease Dementy and Lewy Body Dementia ¿To evaluate whether there are differences in the brain distribution of the neuroinflammation marker [18F]GE-180 within the groups AD dementia, MCIa converters and MCIa non converters, which are related to the severity clinical features and disease duration of patients ¿To evaluate whether there are differences in the brain distribution of the neuroinflammation marker [18F]GE-180 between the groups of MCIa converters and MCIa non converters ;Primary end point(s): Evaluation of differences in the brain distribution of the neuroinflammation marker [18F]GE-180 in the brain of patients affected by AD dementia, as compared with patients affected by MCIa converting in dementia at follow up, and patients with MCIa non converting to dementia at follow-up.;Timepoint(s) of evaluation of this end point: At 16th months from study start a first interim analysis will be performed to assess data in patients recruited up to this time point and reevaluate whether primary end-point will be achieved with a number of patients lower than expected. A final analysis will be performed at 36 months after enrollment of first patient

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Secondary

Measure	Time frame
Secondary end point(s): ¿ Correlation of brain distribution of the neuroinflammation marker [18F]GE-180 in single patients with a brain RMN marker of the noradrenergic brain nucleus Locus Coeruleus assessed on MRI previously performed in the same patients; ¿ Analysis of differences in the brain distribution of the neuroinflammation marker [18F]GE-180 in the brain of patients affected by AD dementia as compared with patients affected by fronto-temporal dementia, Parkinson's Disease Dementia and Lewy Body Dementia ; ¿ Analysis differences in the brain distribution of the neuroinflammation marker [18F]GE-180 within the groups AD dementia, MCIa converters and MCIa non converters, which are related to the severity clinical features and disease duration of patients; ¿ To evaluate whether there are differences in the brain distribution of the neuroinflammation marker [18F]GE-180 between the groups of MCIa converters and MCIa non converters;Timepoint(s) of evaluation of this end point: A final analysis will be performed at 36 months after enrollment of first patient; A final analysis will be performed at 36 months after enrollment of first patient; A final analysis will be performed at 36 months after enrollment of first patient; A final analysis will be performed at 36 months after enrollment of first patient	—

Measure

Time frame

Secondary end point(s): ¿ Correlation of brain distribution of the neuroinflammation marker [18F]GE-180 in single patients with a brain RMN marker of the noradrenergic brain nucleus Locus Coeruleus assessed on MRI previously performed in the same patients; ¿ Analysis of differences in the brain distribution of the neuroinflammation marker [18F]GE-180 in the brain of patients affected by AD dementia as compared with patients affected by fronto-temporal dementia, Parkinson's Disease Dementia and Lewy Body Dementia ; ¿ Analysis differences in the brain distribution of the neuroinflammation marker [18F]GE-180 within the groups AD dementia, MCIa converters and MCIa non converters, which are related to the severity clinical features and disease duration of patients; ¿ To evaluate whether there are differences in the brain distribution of the neuroinflammation marker [18F]GE-180 between the groups of MCIa converters and MCIa non converters;Timepoint(s) of evaluation of this end point: A final analysis will be performed at 36 months after enrollment of first patient; A final analysis will be performed at 36 months after enrollment of first patient; A final analysis will be performed at 36 months after enrollment of first patient; A final analysis will be performed at 36 months after enrollment of first patient

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Countries

Italy

Contacts

Public ContactU.O. NEUROLOGIA - NEUROFISIOPATOLOG

U.O. NEUROLOGIA - NEUROFISIOPATOLOGIA

f.giorgi@ao-pisa.toscana.it050992443

Outcome results

None listed

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