Study on Vagus Nerve Stimulation and Sodium Oxybate for Patients with Cerebral Amyloid Angiopathy

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What is this study about?

This clinical trial is focused on studying a condition known as cerebral amyloid angiopathy (CAA). CAA is a disease where protein deposits, called amyloid, build up in the walls of the blood vessels in the brain. This can lead to problems such as bleeding in the brain. The study is exploring whether two treatments, non-invasive vagus nerve stimulation (nVNS) and a medication called sodium oxybate, can help clear these amyloid deposits from the brain’s blood vessels. Sodium oxybate is a central nervous system depressant that is taken as an oral solution.

The purpose of the study is to see if these treatments can stimulate the brain’s cleaning system, known as the glymphatic system, to remove amyloid deposits more effectively. Participants in the study will receive either nVNS, sodium oxybate, or both. Some participants may receive a placebo. The study will last for a period of up to 12 months, during which the effects of the treatments will be monitored and compared to the participants’ condition before starting the treatment.

Throughout the study, participants will have regular check-ups to assess the levels of amyloid in their cerebrospinal fluid, which is the fluid surrounding the brain and spinal cord. This will involve a procedure called a lumbar puncture, where a small amount of fluid is taken from the lower back. The study aims to determine if the treatments can reduce amyloid levels and improve the condition of patients with cerebral amyloid angiopathy.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria related to cerebral amyloid angiopathy (CAA).

Written informed consent is required to participate.

2 initial assessment

An initial assessment is conducted to establish baseline levels of amyloid-beta (Aβ) in the cerebrospinal fluid (CSF).

This involves a lumbar puncture to collect CSF samples.

3 treatment phase

The treatment phase involves the administration of sodium oxybate orally.

The dosage and frequency are determined by the study protocol and are aimed at stimulating the clearance of amyloid-beta from cerebral blood vessels.

Non-invasive vagus nerve stimulation (nVNS) may also be used as part of the treatment.

4 midpoint assessment

At 3 months, a midpoint assessment is conducted to measure the levels of Aβ 40 and 42 in the CSF.

This involves another lumbar puncture to collect CSF samples.

5 continuation of treatment

The treatment continues as per the study protocol, maintaining the administration of sodium oxybate and possibly nVNS.

6 final assessment

At 6 months, a final assessment is conducted to evaluate the changes in Aβ levels in the CSF.

A lumbar puncture is performed to obtain the necessary CSF samples.

7 completion of study

The study concludes with the analysis of collected data to determine the effectiveness of the treatment in stimulating amyloid clearance.

Participants are informed of the study’s findings and any relevant follow-up actions.

Who Can Join the Study?

Patients must have a condition called Cerebral Amyloid Angiopathy (CAA), which affects the blood vessels in the brain.
For patients with a specific type of CAA called D-CAA, they must have a proven APP mutation (a genetic change) or a history of at least one lobar ICH (a type of brain bleed) and a positive family history for D-CAA in at least one close family member.
Patients with D-CAA must be at least 30 years old.
They should have had no more than two symptomatic ICHs, with the last one occurring more than a year ago.
They should have at least one haemorrhagic marker (such as signs of bleeding in the brain) or one non-haemorrhagic marker (such as changes in brain tissue seen on scans).
If they are presymptomatic, meaning they have no symptoms yet, they must be aware that they have D-CAA.
For patients with probable sCAA, they must meet the Modified Boston criteria 2.0 and be at least 50 years old.
They should have had no more than two symptomatic ICHs, with the last one occurring more than a year ago.
For patients with provisional CAA, they must not meet the criteria for probable sCAA due to deep haemorrhagic lesions but have mostly lobar microbleeds and cortical superficial siderosis present.
They must be at least 50 years old and have had no more than two symptomatic ICHs, with the last one occurring more than a year ago.
Patients must provide written informed consent, meaning they agree to participate in the study after understanding all the details.

Who Cannot Join the Study?

Patients who have a history of severe allergic reactions to the study treatments.
Individuals with significant heart problems that are not well controlled.
People with severe kidney or liver disease.
Patients who are currently participating in another clinical trial.
Individuals who are pregnant or breastfeeding.
People with a history of drug or alcohol abuse within the past year.
Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate.
Individuals who are unable to follow the study procedures or attend the required visits.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Academisch Ziekenhuis Leiden	Leiden	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	31.12.2023

Trial locations

Investigated drugs:

Sodium Oxybate

Non-invasive vagus nerve stimulation (nVNS) is a therapy that involves using a device to gently stimulate the vagus nerve, which is a major nerve in the body. This stimulation is done without any surgery or invasive procedures. The goal of this therapy in the trial is to help clear amyloid-beta from the blood vessels in the brain by activating the glymphatic system, which is responsible for cleaning waste from the brain.

Low-sodium oxybate (LXB) is a medication that is being tested to see if it can help remove amyloid-beta from the brain’s blood vessels. It is a form of oxybate with reduced sodium content, which may be beneficial for patients who need to manage their sodium intake. In this trial, LXB is used to see if it can enhance the brain’s natural cleaning process, known as the glymphatic system, to improve the condition of patients with cerebral amyloid angiopathy.

Investigated diseases:

Cerebral amyloid angiopathy

Cerebral amyloid angiopathy – This disease involves the accumulation of amyloid protein deposits in the walls of the blood vessels in the brain. Over time, these deposits can lead to the weakening of the blood vessel walls, making them more prone to bleeding. The condition is often associated with aging and is more common in older adults. As the disease progresses, it can cause small, often unnoticed, brain hemorrhages, which may accumulate and lead to cognitive decline. Symptoms can vary but may include headaches, confusion, and neurological deficits. The progression of the disease can be slow, with symptoms worsening gradually over time.

Trial ID:

2023-506128-10-00

NCT ID:

NCT06421532

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Vagus Nerve Stimulation and Sodium Oxybate for Patients with Cerebral Amyloid Angiopathy

What is this study about?

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