NeuroPET GBG 001 - Mapping pathogenic processes associated with the development of neurodegenerative disorders using novel neuroimaging modalities

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Vaestra Goetalandsregionen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

8 Oct 2024 → ongoing

Decision date (initial)

2024-10-08

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-513499-16-00

EudraCT number

2018-000801-21

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

To establish and validate the use of tau PET for the early identification of subjects at risk of developing a neurodegenerative disease and for the mapping of tau pathology over different disease stages.

Secondary objectives 5

1. To examine interrelationships of tau PET measures with changes in cognition and other navel and established biomarkers for neurodegenerative diseases.
2. To understand differences between dementia disorders in terms of underlying tau­related pathogenic processes.
3. To map the longitudinal development of tau-related pathogenic processes over different disease stages.
4. To define spatial and temporal differences between purely age-related and disease­related tau aggregation.
5. To establish tau PET as a tool to evaluate potential treatment outcomes in neurodegenerative diseases associated with tau pathology.

Conditions and MedDRA coding

Neurodegenerative diseases

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Signed informed consent form
2. ≥18 years old
3. 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.
4. 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.
5. 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.
6. Fertile women willing to use a highly effective contraception during a period of 90 days after each administration. Such methods include: a) Combined ( estrogen and progestogen containing ) hormonal contraception associated with inhibition of ovalution. b) Progestogen-only hormonal contraception associated with inhibition of ovulation c) lntrauterine device (IUD) d)lntrauterine hormone-releasing system ( IUS)
7. 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 10

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Standardized uptake value ratios of [18]F-R0948 in selected cortical brain regions (normalized to a reference region).

Secondary endpoints 4

1. 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
2. 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)
3. Cognitive performance as assessed by neuropsychological testing
4. Plasma measures of A􀀈40, A􀀈42, NFL and p-tau

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Vaestra Goetalandsregionen

Sponsor organisation

Vaestra Goetalandsregionen

Address

Regionens Hus

City

Vänersborg

Postcode

462 80

Country

Sweden

Scientific contact point

Organisation

Vaestra Goetalandsregionen

Contact name

Michael Schöll

Public contact point

Organisation

Vaestra Goetalandsregionen

Contact name

Michael Schöll

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications