MAIN RESEARCH PROJECTS

THE AMBAR PROJECT

AMBAR FINDINGS DEMONSTRATE EFFICACY TO STABILIZE ALZHEIMER’S IN TREATED PATIENTS

AMBAR is an international and multicenter clinical trial designed by Grifols in collaboration with Fundació ACE in Barcelona (Spain) and the Alzheimer’s Disease Research Center in Pittsburgh (U.S.). Following a successful pilot study and completion of phases I and II, phase IIb/III aimed to evaluate the efficacy and safety of plasma exchange to stabilize the disease progression of Alzheimer’s (AD). 

The clinical trial lasted for 14 months and was split into two phases: an initial phase common to all patients, followed by a second phase in which different volumes and concentrations of albumin were administered to different groups. In some cases, the albumin was alternated with intravenous immunoglobulin to correct a possible endogenous immunoglobulin decrease. The plasma exchange in the placebo-controlled group was simulated in both phases. 

Data analysis was performed on the total study population compared to the placebo group and included the following study arms: a) comparison of each of the three treatment groups. All three groups received plasma exchange with different doses of albumin and immunoglobulin; b) an arm that included all patients treated with plasma exchange; and c) an arm that included all patients treated with plasma exchange analyzed by disease severity: mild AD and moderate AD.

Throughout 2019, Grifols presented the findings of its AMBAR clinical trial at several international congresses. All results point to the positive effects of the treatment to slow down the progression of the disease in patients in the mild to moderate stages. Grifols concluded its AMBAR clinical trial after unveiling the latest findings at the 2019 Clinical Trials on Alzheimer’s Disease Congress (CTAD), held in December 2019 in San Diego (U.S.). The company plans on launching an AMBAR II study.

The result of 15 years of rigorous scientific research, these promising findings reinforce Grifols’ research on plasma protein replacement therapies.

OBJECTIVES AND METHODS

Primary objective

To evaluate the efficacy of the treatment by measuring variations in:

  • Patients’ cognitive function
  • The ability to carry out daily activities

Evaluation method

  • Psychometric scales
  • Neuroimaging
  • Neuropsychological Test
  • Mini-Mental State Examination (MMSE)

CONGRESSES AND FINDINGS PRESENTED

PRIMARY ENDPOINTS
Secondary endpoints
AMBAR project

Research Design

Plasma Exchange With Albumin as a Treatment

Patients participating in the AMBAR clinical trial were treated with regular plasma exchanges: a safe, well-known therapy based on the plasmapheresis technique.

Plasma exchanges entail extracting blood from the patient and separating its cellular components, including plasma. The plasma is replaced with albumin (in most cases), added to the remaining blood cells and injected back into the patient.

The therapy, which doesn’t require anesthesia, is usually administered in hospitals or outpatient centers and used to treat a range of blood, neurological and autoimmune diseases.

 

15 Years of Alzheimer’s Research

2004

Grifols starts its first lines of research in Alzheimer’s in collaboration with Fundació ACE in Barcelona (Spain) and the University of Pittsburgh’s Alzheimer’s Disease Research Center (U.S.)

2012

AMBAR clinical trial commences based on the combination of plasma exchange with albumin and IVIG as a possible treatment for Alzheimer’s disease.

2015

The intermediate results demonstrate the tolerability and safety of the treatment, establishing the requisite conditions for the trial to continue.

03/2018

The experimental phase of AMBAR concludes.

10/2018

AMBAR phase IIb/III results demonstrate a significant stabilization in disease progression in patients with moderate AD.

2019

Ongoing analysis of AMBAR variables and conclusion of the clinical trial. New finding confirms its efficacy to treat patients with mild and moderate AD. Grifols announces the launch of AMBAR II.

SINCE 2004 GRIFOLS’ SCIENTIFIC RESEARCH HAS BEEN FOCUSED ON FINDING A TREATMENT TO DELAY THE PROGRESSION OF Alzheimer’s, THAT AFFECTS MORE THAN 35 MILLION PEOPLE THROUGHOUT THE WORLD AND COULD REACH 82 MILLION IN 2030