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Alkahest's plasma based IV infusion passes safety trial
HowDoYouDeal
Posted: Sunday, November 10, 2019 9:07 PM
Joined: 2/17/2019
Posts: 277


GRF6019 represents an innovative approach to effectively treating Alzheimer disease by targeting multiple underlying mechanisms of disease, and these data support the continued development of GRF6019 and other plasma protein fractions in Alzheimer disease.”

The randomized, double-blind, dose comparison phase 2 trial (NCT03520998) evaluated the safety, tolerability, and feasibility of GRF6019, a plasma-derived product, administered as an IV, in 40 subjects with mild to moderate Alzheimer disease for 6 months. Subjects eligible for the study were 60–90 years of age, received a diagnosis of probable Alzheimer disease, had a MMSE score of 12–24 inclusive, and a Modified Hachinski ischemia score of ≤4.

Subjects were randomized 1:1 to 1 infusion per day of 100 mL or 250 mL of active treatment for 5 consecutive days at weeks 1 and 13, with a treatment-free interval of 12 weeks following each dose, for a total of 10 doses per subject.

The primary outcome measure included the incidence of treatment-emergent adverse effects, while secondary measures included changes in scores on the MMSE, ADAS-Cog11, the Grooved Pegboard Test, the Category Fluency Test, the CDR-SB, the ADCS-ADL23, the Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC), the Neuropsychiatric Inventory Questionnaire (NPI-Q), and the Savonix Neurocognitive Assessments and Digit Span.

Alkahest also intends to study GRF6019 in severe Alzheimer disease.