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PET brain scan tracer measures a brain barrier protein in neurodegenerative disease

Tests a radioactive brain scan tracer in adults with Alzheimer's, amyloid angiopathy or Parkinson's.

Key facts

Who runs it
Universitair Medisch Centrum Groningen
Where
Groningen, NetherlandsSee the site
Registry title
Evaluation of [18F]MC225 to measure P-glycoprotein function in neurodegenerative disease
Status
Not yet recruiting
Phase
Phase 2
People taking part
30 people, planned
Started
1 Nov 2021
Planned end
30 Sept 2025
Type of study
Interventional
Record updated
19 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Alzheimer's disease, sporadic cerebral amyloid angiopathy (sCAA) or Parkinson's disease. Researchers study how a brain scan tracer shows P-glycoprotein function.

Age
18 years or older. People with sCAA must be 50 years or older.
Sex
All sexes can join.
Disease stage
Alzheimer's disease with cognitive decline that gets worse over time, confirmed by a team of specialists. sCAA that meets the Boston Criteria 2.0 (probable CAA). Parkinson's disease diagnosed by a neurologist, with slowed movement and stiffness, rest tremor or balance problems.
Earlier treatment
People must not take medicines known to affect P-gp, such as digoxine, verapamil, NSAIDs or St. John's Wort. People with sCAA must have had no symptomatic brain bleed in the past 90 days.
Biomarker or test result
Alzheimer's disease: signs in spinal fluid or on scans, such as amyloid in the brain (low Aβ42 in CSF or positive PIB-PET) and nerve cell damage (raised tau, lower FDG uptake or temporal lobe shrinkage). sCAA: bleed marks on T2*-weighted MRI as described in the record.

Main reasons for not taking part

  • History of epilepsy, major depression or schizophrenia
  • Claustrophobia
  • Use of medicines that affect P-gp
  • Metal objects, implants or a pacemaker in the body
  • Pregnancy or breastfeeding, kidney failure (<45 ml/min) or allergy to MR contrast

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

  • Alzheimer’s disease patients: Patients who meet the criteria for Alzheimer’s disease and are mentally competent to give informed consent: 1. Documented cognitive decline 2. Progressive course of cognitive decline 3. Complaints in at least one of the following areas:  a. Memory  b. Language  c. Visuospatial functions  d. Executive functions 4. Absence of cerebrovascular disease or signs of other neurodegenerative disease except for Alzheimer’s disease In addition, patients must show biomarkers positive for AD: • Amyloid deposition in the brain demonstrated by:   • Low Aβ42 in CSF and/or • Positive amyloid imaging on PIB-PET • Evidence of neuronal damage shown by one or more of the following:   • Increased tau or phosphorylated tau in CSF • Decreased FDG uptake in the parietotemporal lobe • Disproportionate atrophy of the medial, basal, and lateral temporal lobes, generalized atrophy and/or biparietal atrophy The diagnosis of Alzheimer’s disease must be confirmed by a multidisciplinary team including neurologists, psychologists, and internists. sCAA patients: Patients must meet the criteria for probable CAA as defined by the Boston Criteria 2.0, and must be mentally competent to provide informed consent and have had no symptomatic brain hemorrhage in the past 90 days. Inclusion criteria: 1. Pathological confirmation not required 2. Age ≥50 years 3. Clinical presentation with at least one of the following:   • Spontaneous intracerebral hemorrhage   • Transient focal neurological episodes   • Cognitive impairment or dementia MRI criteria Must demonstrate either: • Option A: At least two strictly lobar hemorrhagic lesions on T2*-weighted MRI in any combination:  • Intracerebral hemorrhage  • Cerebral microbleeds  • Cortical superficial siderosis (multiple distinct foci)  • Convexity subarachnoid hemorrhage (multiple distinct foci)  OR • Option B: One lobar hemorrhagic lesion plus one white matter feature:  • Severe perivascular spaces in the centrum semiovale (>20 visible in one hemisphere)  • Multispot pattern of white matter hyperintensities (>10 subcortical FLAIR dots bilaterally) In the absence of: • Deep hemorrhagic lesions on T2*-weighted MRI • Any other cause of hemorrhagic lesions • Cerebellar hemorrhages (not counted as lobar or deep) Parkinson’s disease patients: Patients must be diagnosed with PD by a neurologist and meet the following criteria: • Presence of bradykinesia and at least one of the following:  • Rigidity  • Rest tremor  • Postural instability (not related to visual, cerebellar, or proprioceptive causes) • No other explanation for the symptoms on MRI • Absence of cerebrovascular disease or signs of other neurodegenerative diseases except for Parkinson’s disease

Who cannot take part

  • A potential subject who meets any of the following criteria will be excluded from participation in this study: - History of neuropsychiatric disorders such as epilepsy, major depression, or schizophrenia - Claustrophobia Use of medication with known P-gp influence, according to the Farmacotherapeutisch Kompas: - Digoxine - Dabigatran - Everolimus - Verapamil - Tacrolimus - Rosuvastatin - Lercanidipin - Repaglinide - Aliskiren - Aminoglycosides - Vancomycine - NSAIDs - Acyclovir - Trimethoprim - Amfotericine B - Ciprofloxacine - H2 receptor antagonists - Methotrexate - St. John’s Wort - Loperamide - Rifampicine - Carbamazepine - Fenobarbital - Fenytoine - Hypericum - Primidon The list contains pharmaceuticals with P-gp influence mentioned in the FK, for other pharmaceuticals, the influence on P-gp will be checked using kennisbank KNMP or Pubmed) Exclusion Criteria contrast-enhanced MRI: - Metallic objects or fragments placed in the body - Artificial metal joints or implants - Pacemaker - Clips/Stents in blood vessel - Claustrophobia - a history of mastocytosis - Pregnancy or breastfeeding - Kidney failure (< 45 ml/min) - Allergy to MR contrast or dye - Tattoo (>20cm)

Where in Netherlands

  • Universitair Medisch Centrum GroningenGroningen, NetherlandsNot yet recruiting

About the trial

What the trial wants to find out

Evaluation of [18F]MC225 to measure the P-glycoprotein function in Alzheimer’s disease, sCAA and Parkinson’s disease.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
BBB-PET; Evaluation of [18F]MC225 to measure P-glycoprotein function in neurodegenerative disease
Plain-language title
PET brain scan tracer measures a brain barrier protein in neurodegenerative diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
19 January 2026