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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

7 criteria

  • 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 trial?

10 criteria

  • 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.
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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.

What is already known about the treatment

BMS-986446 – This medication is administered as an injection and is currently being studied in clinical trials for its potential use in treating early Alzheimer's disease. It is an investigational drug, meaning it is not yet approved for general medical use, but it is being evaluated for its safety and effectiveness. The main therapeutic indication for BMS-986446 is to improve cognitive function and general daily functioning in individuals with early Alzheimer's disease. At the molecular level, it works as an anti-MTBR tau monoclonal antibody, targeting tau proteins that are believed to play a role in the progression of Alzheimer's disease. It is classified pharmacologically as a monoclonal antibody.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504840-32-00Protocol codeCN008-0003Estimated enrolment433 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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