[18F]MC225 for Alzheimer's disease|Sporadic cerebral amyloid angiopathy|Parkinson's disease

Inclusion criteria

• {"criterion_text":"- Alzheimer’s disease patients: Patients who meet the criteria for Alzheimer’s disease and are mentally competent to give informed consent: 1.\tDocumented cognitive decline 2.\tProgressive course of cognitive decline 3.\tComplaints in at least one of the following areas:  a. Memory  b. Language  c. Visuospatial functions  d. Executive functions 4.\tAbsence of cerebrovascular disease or signs of other neurodegenerative disease except for Alzheimer’s disease In addition, patients must show biomarkers positive for AD: •\tAmyloid deposition in the brain demonstrated by:   • Low Aβ42 in CSF and/or • Positive amyloid imaging on PIB-PET •\tEvidence 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.\tPathological confirmation not required 2.\tAge ≥50 years 3.\tClinical presentation with at least one of the following:   • Spontaneous intracerebral hemorrhage  \t• Transient focal neurological episodes  \t• Cognitive impairment or dementia MRI criteria Must demonstrate either: •\tOption 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 •\tOption 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: •\tDeep hemorrhagic lesions on T2*-weighted MRI •\tAny other cause of hemorrhagic lesions •\tCerebellar 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: •\tPresence of bradykinesia and at least one of the following:  • Rigidity  • Rest tremor  • Postural instability (not related to visual, cerebellar, or proprioceptive causes) •\tNo other explanation for the symptoms on MRI •\tAbsence of cerebrovascular disease or signs of other neurodegenerative diseases except for Parkinson’s disease"}

Exclusion criteria

• {"criterion_text":"- 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)"}

Primary endpoints

• {"endpoint_text":"- Regional PET tracer uptake en influx waarden van [18F]MC225","definition_or_measurement_approach":"Regional PET tracer uptake and influx values of [18F]MC225 measured by PET (regional PET quantification of uptake and influx)."}

Secondary endpoints

• {"endpoint_text":"- CBF - cerebral blood flow values obtained with [15O]H2O PET MRI (vessel architecture) VAI measurements Arterial samples replaced with less invasive venous samples","definition_or_measurement_approach":"[15O]H2O PET/MRI to obtain cerebral blood flow values; VAI measurements; arterial sampling replaced with venous sampling."}

Netherlands

Earliest CTIS Part Ii Submission Date

30-11-2024

Latest Decision Or Authorization Date

19-01-2026

Processing Time Days

415

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Universitair Medisch Centrum Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands