Grifols presents its latest Alzheimer's clinical trial data
Neuroimaging shows AMBAR clinical trial's positive effects in patients with mild-to-moderate Alzheimer's disease
BARCELONA, Spain, Dec. 6, 2019 /PRNewswire/ -- Grifols (MCE: GRF, MCE: GRF.P, NASDAQ: GRFS), a leading global producer of plasma-derived medicines, today concluded more than a year of encouraging results of its AMBAR (Alzheimer Management by Albumin Replacement) clinical trial with the presentation of new neuroimaging data that show the reduction in the progression of the disease in patients with mild-to-moderate Alzheimer's disease.
These findings, released at the Clinical Trials on Alzheimer's Disease (CTAD) Conference 2019 in San Diego, Calif. (USA), strengthen Grifols' investigative approach using Plasma Protein Replacement Therapies.
The neuroimaging, which was measured by the FDG-PET1 technique, shows positive results particularly in patients receiving both albumin and immunoglobulin (IG). In comparison with the placebo group, these patients had less reduction of brain glucose metabolism over the 14 months of the clinical trial. This suggests that neuronal damage was reduced in these patients (see figure).
The images display the extension and distribution of the dark spots that relate to the reduction of glucose metabolism in the brain. Fewer and lighter spots suggest less neuronal damage, which is observed in the patients receiving both albumin and IG compared with placebo.
Grifols presented the first AMBAR results at the 11th CTAD Conference in Barcelona in October 2018. The primary efficacy endpoints, the ADAS-Cog2 and ADCS-ADL3 scales, showed a 61% reduction in disease progression for both measures in the cohort of patients with moderate Alzheimer's.
Additional data covering the secondary endpoints of the study, such as memory and language, were presented at the 14th International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) in Lisbon (Portugal) in March 2019, and showed a positive impact in both mild and moderate patients.
Results of other relevant endpoints, CDR-Sb4 and ADCS-CGIC5, evaluating both functional and cognitive capacity, were presented at the Alzheimer's Association International Conference (AAIC) 2019 in Los Angeles, Calif. (USA) in July, and also pointed in the same direction when considering all treated patients together.
The CDR-Sb scale – which assesses memory, orientation, judgment, community affairs, home and hobbies, and personal care – showed a 71% reduction in clinical decline with respect to placebo in patients treated as a whole and in all three clinical trial treatment arms analyzed separately.