Study of RO7126209 safety and effects given by intravenous infusion in patients with early stage or mild to moderate Alzheimer’s disease

What is this study about?

This study focuses on patients with Alzheimer’s Disease, including those with early signs (prodromal) and mild to moderate forms of the condition. The study will test a new medication called RO7126209 (trontinemab), which is given through intravenous infusion. Some participants will receive the study medication while others will receive a placebo.

The main purpose of this research is to determine if RO7126209 is safe and well-tolerated when given in multiple increasing doses, and to understand how the medication works in the body. The study will also examine how the drug affects the buildup of amyloid (a protein associated with Alzheimer’s Disease) in the brain using special brain scans called PET scans.

During the study, participants will receive multiple doses of either the study medication or placebo through an infusion into their vein. The study consists of four parts, with different dosing schedules in each part. Throughout the study, participants will undergo various medical examinations, including brain scans, blood tests, and assessments of their thinking abilities. Their safety will be closely monitored through regular check-ups and tests.

1 Initial evaluation

Your eligibility will be assessed based on the following criteria:

– Age between 50 and 85 years

– Diagnosis of early or moderate Alzheimer’s disease

– Score of 18-28 points on the Mini-Mental State Examination

– Positive brain scan showing amyloid protein buildup performed within the last 12 months

2 Treatment groups assignment

You will be randomly assigned to receive either:

– Trontinemab through intravenous infusion (medication delivered directly into your vein)

– Placebo (a substance with no active medication)

The assignment is double-blind, meaning neither you nor your doctor will know which treatment you receive

3 Brain imaging procedures

Throughout the study, you will undergo:

– Brain scans using Florbetapir F18 to measure amyloid protein levels

– MRI (Magnetic Resonance Imaging) scans to monitor brain safety

4 Monitoring and assessments

Regular check-ups will include:

– Physical and neurological examinations

– Blood tests

– Heart monitoring (ECG)

– Vital signs measurements

– Collection of spinal fluid samples to measure medication levels

5 Study duration

The study continues until September 2027

Your participation may include multiple doses of the study medication

Regular monitoring will continue throughout your participation to ensure safety

Who Can Join the Study?

Must be between 50 and 85 years old at the time of screening
Must have either:
– Mild to moderate Alzheimer’s disease with clear symptoms, or
– Early signs of Alzheimer’s disease with mild memory problems
Must score between 18 and 28 points on the Mini-Mental State Examination (a test that evaluates memory and thinking abilities) within 84 days before starting the study
Must have a Clinical Dementia Rating score of 0.5, 1, or 2 (a scale that measures the severity of dementia symptoms) within 84 days before starting the study
Must have a positive brain scan showing presence of amyloid (a protein associated with Alzheimer’s disease) within 12 months before starting the study
If currently taking medications for Alzheimer’s symptoms, the dose must have remained unchanged for at least 8 weeks before starting the study and must stay the same until assigned to a treatment group

Who Cannot Join the Study?

Age under 18 years old
Pregnancy or breastfeeding
History of severe allergic reactions to medications
Participation in another clinical trial within the past 30 days
Significant liver disease (problems with liver function)
Significant kidney disease (problems with kidney function)
Uncontrolled high blood pressure
History of heart disease or heart attack in the past 6 months
Active or recent cancer within the past 5 years
History of blood clotting disorders
Severe psychiatric conditions that could interfere with the study
Use of medications that could interact with the study drug
Alcohol or drug abuse within the past year
Inability to provide informed consent
Major surgery planned during the study period
History of brain hemorrhage (bleeding in the brain)
Severe neurological conditions other than Alzheimer’s disease

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Hospital Universitari General De Catalunya	Sant Cugat Del Valles	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Fundacio Ace Institut Catala De Neurociencies Aplicades	Barcelona	Spain
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain
Policlinica Gipuzkoa S.A.	Donostia / San Sebastian	Spain
Vitamed Galaj I Cichomski Sp. j.	Bydgoszcz	Poland
Clinical Research Center Sp. z o.o. Medic-R sp.k.	Poznan	Poland
Euromedis Sp. z o.o.	Szczecin	Poland
Hospital Clinic De Barcelona	Barcelona	Spain
NZOZ Wrocławskie Centrum Alzheimerowskie	Wroclaw	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	17.03.2021
Spain	Not recruiting	17.03.2021

Trial locations

Investigated drugs:

RO7126209 is an investigational medication administered through intravenous infusion (given into a vein). It is being studied for the treatment of people with early stages of Alzheimer’s disease, including those with prodromal (very early) and mild to moderate symptoms. The medication is being tested to understand how well the body tolerates it, how it moves through the body, and what effects it has on the disease process.

Alzheimer’s disease – A progressive brain disorder that gradually destroys memory, thinking skills, and the ability to carry out simple tasks. The disease begins slowly and first affects parts of the brain that control memory, thinking, and language. Over time, symptoms get worse as more parts of the brain become affected. The disease causes brain cells to degenerate and die, leading to a decline in cognitive and behavioral functions. Changes in the brain may begin years before the first symptoms appear.

Trial ID:

2023-509678-52-00

Protocol code:

BP42155

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of RO7126209 safety and effects given by intravenous infusion in patients with early stage or mild to moderate Alzheimer’s disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?