Joined: 2/17/2019
Posts: 380
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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.
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