Study of BMS-986446 for Early Alzheimer’s Disease Patients

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What is this study about?

This clinical trial is focused on studying Early Alzheimer’s Disease, a condition that affects memory and thinking skills. The study will evaluate a new treatment called BMS-986446, which is an anti-MTBR tau monoclonal antibody. This treatment is designed to target specific proteins in the brain that are believed to play a role in Alzheimer’s Disease. Participants in the study will receive either the new treatment or a placebo, which is a substance with no active medication.

The purpose of the study is to assess the effectiveness, safety, and tolerability of the treatment over a period of time. Participants will be randomly assigned to receive either the treatment or the placebo. The study will last until Week 76, during which time changes in thinking and general functioning will be monitored. This will be measured using a tool called the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB), which helps to evaluate the severity of dementia symptoms.

In addition to the main treatment, the study will also use Florquinitau F-18, a solution for injection, to help measure changes in the brain. This will be done using a PET scan, a type of imaging test that allows doctors to see how the brain is functioning. The study aims to provide valuable information about how the new treatment affects brain tau deposition and overall cognitive function in people with Early Alzheimer’s Disease.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria related to early Alzheimer’s disease. This includes assessments of memory and cognitive function.

2 initial assessment

An initial assessment is conducted to establish baseline measurements. This includes cognitive tests and possibly imaging studies to evaluate brain tau levels.

3 treatment phase

During the treatment phase, the medication PRX005 is administered as a solution for injection through an intravenous route. The dosage is 50 mg/ml. The frequency and duration of administration are determined by the study protocol.

Additionally, Florquinitau F-18 may be used for imaging purposes, also administered intravenously.

4 monitoring and follow-up

Regular monitoring is conducted to assess the effects of the treatment. This includes cognitive assessments and possibly imaging studies to track changes in brain tau deposition.

The main objective is to observe changes in thinking and general functioning by the end of the treatment period at Week 76.

5 final assessment

At the end of the study period, a final assessment is conducted to evaluate the overall impact of the treatment on cognitive function and daily living activities.

Who Can Join the Study?

The patient must have mild cognitive impairment or mild Alzheimer’s disease dementia. This means they have some memory problems but can still do most daily activities.
The patient should have a Global Clinical Dementia Rating (CDR) score between 0.5 and 1.0. This is a way to measure how much the disease affects their thinking and memory.
The patient must show evidence of Alzheimer’s disease pathology. This means there are signs in their body that they have Alzheimer’s disease.
The patient should have objective impairment in episodic memory. This means they have trouble remembering events or experiences, shown by scoring at least 1 standard deviation below the average for their age on a specific memory test.
The patient must have a Mini Mental Status Examination (MMSE) score between 22 and 30. This is a test that checks their mental functions like memory and understanding.
The patient must be within a certain age range, which includes adults and older adults.
Both male and female patients can participate in the study.

Who Cannot Join the Study?

Patients with any other serious health condition that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent major surgery or are planning to have one during the study period.
Patients with a history of drug or alcohol abuse.
Patients who are unable to comply with the study procedures.
Patients who have a known allergy to any of the study medications.
Patients who are pregnant or breastfeeding.
Patients with a history of severe mental health disorders.
Patients who have been diagnosed with a different type of dementia.
Patients who have a significant neurological disorder 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
Katholieke Universiteit te Leuven	Leuven	Belgium
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Hospital Universitari General De Catalunya	Sant Cugat Del Valles	Spain
Hospital Del Mar	Barcelona	Spain
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
Hospital Universitari De Santa Maria	Lleida	Spain
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Hospital Clinic De Barcelona	Barcelona	Spain
Cklhbkkdy Uhzzmtcfcpqjme Slmneysdu	Woluwe-Saint-Lambert	Belgium
Hzrcjeph Dw Lc Sydma Cguk I Syrz Per	Barcelona	Spain
Udwpsgqpsm Ow Awwhhdk	Edegem	Belgium
Hqvvonsy Vqzi dtcmucbo	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	30.08.2024
Spain	Not recruiting	30.08.2024
Sweden	Not recruiting	30.08.2024

Trial locations

Investigated drugs:

BMS-986446 is an experimental medication being studied for its potential to help people with early Alzheimer’s disease. It is a type of drug known as a monoclonal antibody, which is designed to target and bind to specific proteins in the brain. In this study, BMS-986446 is being tested to see if it can improve thinking and general functioning in patients over a period of time.

Early Alzheimer’s Disease – This condition is a progressive neurological disorder that affects memory, thinking, and behavior. It typically begins with mild memory loss and can lead to difficulties in remembering recent events or conversations. As the disease progresses, individuals may experience confusion, disorientation, and challenges in completing familiar tasks. Changes in mood and personality, such as increased anxiety or irritability, may also occur. Over time, the ability to communicate and perform daily activities can become significantly impaired. The progression of symptoms varies among individuals, but it generally worsens over several years.

Trial ID:

2023-504840-32-00

Protocol code:

CN008-0003

NCT ID:

NCT06268886

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of BMS-986446 for Early Alzheimer’s Disease Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?