Download US Food and Drug Association Approves Human Testing

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Vanderbilt University scientists
have received notification from the
U.S. Food and Drug Administration
(FDA) that testing in humans may
proceed for an investigational new
drug after more than 10 years of
research.
The aim is for the investigational
drug to target major pathologies of
Alzheimer’s disease and selectively
activate a key receptor in the brain.
The researchers believe that the current standard of care for Alzheimer’s
disease (i.e., cholinesterase inhibitors) has a different mechanism of
action. They are hoping to establish,
through future clinical testing, that
the molecule is broadly effective
across a number of cognitive and
neuropsychiatric disorders, including
schizophrenia.
Phase 1 testing will assess drug
safety and tolerability in healthy
volunteer participants—a process
that could take 1 year. If successful,
Phase 2 and 3 studies would include
efficacy assessments in patients with
Alzheimer’s disease and could take 3
to 5 years to complete.
Eli Lilly and AstraZeneca to Co-Develop MEDI1814
as Disease-Modifying Treatment
for Alzheimer’s Disease
Eli Lilly and AstraZeneca announced a worldwide agreement to
co-develop MEDI1814, an antibody selective for amyloid-beta 42
(Aβ42), which is currently in Phase 1 trials as a potential diseasemodifying treatment for Alzheimer’s disease.
The buildup of plaques in the brain containing the peptide amyloid-beta
(Aβ) is one of the characteristics of Alzheimer’s disease. MEDI1814 binds
selectively to Aβ42, a form of Aβ that is particularly associated with the
disease. Binding dose-dependently reduces levels of this peptide, potentially slowing the progression of Alzheimer’s disease.
Source. “Lilly and AstraZeneca to Develop Second Potentially Disease-Modifying Treatment for Alzheimer’s Disease.” (2016, December 9). Retrieved January 30, 2017, from http://prn.
to/2kk3vn7.
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U.S. Food and Drug
Association Approves
Human Testing for
Investigational New
Drug for Alzheimer’s
Disease
Source. “Investigational New Drug
for Alzheimer’s Scheduled for First Study
in Humans.” (2017, January 3). Retrieved
January 30, 2017, from http://bit.ly/2jnp8Dx.
doi:10.3928/00989134-20170214-02
Journal of Gerontological Nursing • Vol. 43, No. 3, 2017
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