Overview
Sponsor-declared trial summary
Cerebrospinal fluid circulation disorder seen in clinically suspected idiopathic normal pressure hydrocephalus, Alzheimers Disease and healthy controls.
To quantify the distribution and rate of elimination of the contrast agent as assessed by repeated MRI in humans. We will also document any adverse events related to the administration of Gadovist
Key facts
- Sponsor
- Region Vaesterbotten
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 13 Jan 2025 → ongoing
- Decision date (initial)
- 2025-01-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Region Västerbotten (ALF‑medel) · Alzheimerfonden · Stiftelsen för strategisk forskning · Vetenskapsrådet
External identifiers
- EU CT number
- 2024-520146-33-00
- EudraCT number
- 2020-005542-42
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic
To quantify the distribution and rate of elimination of the contrast agent as assessed by repeated MRI in humans. We will also document any adverse events related to the administration of Gadovist
Secondary objectives 3
- To investigate the driving mechanism of the flow and if the quantified glymphatic function can be used to predict which INPH patients that will be improved by shunting with CSF shunt
- Determine if there is a difference in quantified glymphatic function between INPH, AD and HC and examine how CSF flow metrics associate with disease-specific biomarkers such as beta amyloid concentration in brain tissue and in cerebrospinal fluid.
- Investigate if CSF flow metrics is predictive of the degree of cognitive impairment and progression in AD.
Conditions and MedDRA coding
Cerebrospinal fluid circulation disorder seen in clinically suspected idiopathic normal pressure hydrocephalus, Alzheimers Disease and healthy controls.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Patients investigated for suspected idiopathic normal pressure hydrocephalus at Umeå University hospital
- Patients with Alzheimers disease.
- Healthy controls
Exclusion criteria 11
- Age <65 for INPH. Age <55 years for AD and HC
- Not able to understand instructions needed for informed concent
- known contradicting allergies
- Known contraindications for magnetic reconance imaging
- Renal impairment (as deffined by blood test at admission)
- Current treatment with anticoagulation medication
- Low threshold for seizures
- History of bronchial asthma
- Previous investigation with gadolinium contrast medium
- Mini mental state examination (MMSE) < 20
- Liver failure
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Time-dependent change in signal intensity on brain MRI after intrathecal contrast administration will be analyzed with indicator dilution algorthim that will be optimized using computational fluid dynamic simulations.
- Registration of possible adverse events related to the intrathecal injection of Gadovist
Secondary endpoints 3
- Comparision between the distribution of the contrast and other MRI-sequences and cerebrospinal fluid dynamic parameters which provides us with information regarding possible driving mechanisms for the distribution.
- Quantified pre-operative glymphatic function will be correlated to clinical improvment after CSF shunting of INPH patients
- Quantified pre-operative glymphatic function will be correlated to clinical progress and beta-amyloid content in HC and AD-patients.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Gadovist 1.0 mmol/ml solution for injection
PRD377690 · Product
- Active substance
- Gadobutrol
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRATHECAL USE
- Authorisation status
- Authorised
- ATC code
- V08CA09 — GADOBUTROL
- Marketing authorisation
- PL 00010/0535
- MA holder
- BAYER PLC
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
VIZAMYL 400 MBq/mL solution for injection
PRD10888598 · Product
- Active substance
- Flutemetamol (18F)
- Substance synonyms
- Flutemetamol F 18, FLUTEMETAMOL F-18
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENUS USE
- Authorisation status
- Authorised
- ATC code
- V09AX04 — -
- Marketing authorisation
- EU/1/14/941/001
- MA holder
- GE HEALTHCARE AS
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Vaesterbotten
- Sponsor organisation
- Region Vaesterbotten
- Address
- Koksvagen 11, Alidhem Alidhem
- City
- Umea
- Postcode
- 907 37
- Country
- Sweden
Scientific contact point
- Organisation
- Region Vaesterbotten
- Contact name
- Prof Malm, Department of neurology
Public contact point
- Organisation
- Region Vaesterbotten
- Contact name
- Prof Malm, Department of neurology
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Sweden | 2025-01-13 | 2025-01-13 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 03 Provningsprotokoll 20260520 | 4 |
| Recruitment arrangements (for publication) | Mandatory field | 1 |
| Subject information and informed consent form (for publication) | Bilaga 5 Patientinformation orginal 211013 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | 07 SmPC Gadobutrol Gadovist | 1 |
| Synopsis of the protocol (for publication) | 04 Synopsis 260326 | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-17 | Sweden | Acceptable 2025-01-13
|
2025-01-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-25 | Sweden | Acceptable 2026-06-01
|
2026-06-01 |