2-(6-[18F]FLUORO-PYRIDIN-3-YL)-9H-DIPYRIDO[2,3-B:3',4'-D]PYRROLE for Neurodegenerative diseases

Inclusion criteria

• {"criterion_text":"- Signed informed consent form\n- ≥18 years old\n- For inclusion in this study the investigator must confirm that the patient is able to understand the information relevant to the decision to participate in the study, appreciate the situation in terms of the treatment and research options and their likely outcomes, and weight the potential risks and benefits of participation in order to come to a decision and communicate the decision.Participants enrolled from SweDOWN study can participate with consent from caregiver.\n- Be included in one of the following studies:H75, subjects born in 1944, see Appendix A.1. H70 Clinical Study, see Appendix B. Epilepsy Study, see Appendix C. Biologiska prediktorer för minne (BioMin) Study, see Appendix D. SWEDOWN study, see Appendix E.\n- Speak and understand Swedish to the extent that an interpreter is not necessary for the patient to fully understand the study information and cognitive tests.\n- Fertile women willing to use a highly effective contraception during a period of 90 days after each administration. Such methods include: a)\tCombined ( estrogen and progestogen containing ) hormonal contraception associated with inhibition of ovalution. b)\tProgestogen-only hormonal contraception associated with inhibition of ovulation c)\tlntrauterine device (IUD) d)lntrauterine hormone-releasing system ( IUS)\n- Male with female reproductive partners to use contraceptives, condoms, at least 90 days after each administration unless the female fertile partner uses highly effective contraceptive drugs during this time."}

Exclusion criteria

• {"criterion_text":"- Person who do not have full decision-making skills. Participants enrolled from SweDOWN-study can participate with consent from caregiver.\n- Exclusion criteria for Lumbar Puncture; 1.Treatment with anticoagulants. 2. Local infection lumbar, skin or soft parts. 3.lncreased intracranial pressure (headache, papilledema)\n- Significant unstable systemic illness, or organ failure, such as terminal cancer, that makes it difficult to participate in the study.\n- Current significant alcohol or substance misuse\n- Significant neurological or psychiatric illness.\n- Refusing lumbar puncture, MRI or PET.\n- Pacemaker or other implanted metallic objects incompatible with MRI investigation.\n- Claustrophobia\n- Female who is pregnant, breast feeding or intends to become pregnant or is of child­bearing potential and not using highly effective contraceptive methods.\n- Positive result of urine dip stick pregnency test taken before each administration of PET-ligand.(At baseline, follow up 2 year and 4 year)"}

Primary endpoints

• {"endpoint_text":"- Standardized uptake value ratios of [18]F-R0948 in selected cortical brain regions (normalized to a reference region).","definition_or_measurement_approach":"Measurement: Standardized uptake value ratios (SUVr) of [18F]-R0948 measured in selected cortical brain regions and normalized to a reference region (PET imaging quantification)."}

Secondary endpoints

• {"endpoint_text":"- CSF measures of sAPPalpha, sAPPbeta, A􀀈38, A􀀈40, A􀀈42, p-tau181, ptau231, total (t-) tau, neurofilament light (NFL), H-FABP, ViliP-1, SNAP-25, dendritic protein neurogranin, CSF/serum albumin ratio, MBP, cytokines, YKL-40, SV2A, and chitotriosidase","definition_or_measurement_approach":"Measurement: Cerebrospinal fluid biomarker assays (specified analytes measured in CSF)."}
• {"endpoint_text":"- Structural and functional measures derived from MRI (cortical volumes and thickness, BOL T signal in selected brain regions, white matter and vascular changes, changes in diffusion)","definition_or_measurement_approach":"Measurement: MRI-derived structural and functional metrics including cortical volumes/thickness, BOLD signal in selected regions, white matter/vascular changes, and diffusion measures."}
• {"endpoint_text":"- Cognitive performance as assessed by neuropsychological testing","definition_or_measurement_approach":"Measurement: Standardised neuropsychological test battery scores assessing cognitive performance."}
• {"endpoint_text":"- Plasma measures of A􀀈40, A􀀈42, NFL and p-tau","definition_or_measurement_approach":"Measurement: Blood plasma biomarker assays for Aβ40, Aβ42, neurofilament light (NFL) and phosphorylated tau (p-tau)."}

Sweden

Earliest CTIS Part Ii Submission Date

21-05-2024

Latest Decision Or Authorization Date

08-10-2024

Processing Time Days

140

Number Of Sites

1

Number Of Participants

300

Primary sponsor

Full Name

Vaestra Goetalandsregionen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden