Efficacy and Safety of Filgrastim in Alzheimer's Disease
Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
Summary
Filgrastim (G-CSF) is widely used for treatment of patients who have a deficiency of white
blood cells. It is also routinely used to stimulate and mobilize stem/progenitor cells for
bone marrow transplantation. In studies of thousands of healthy donor subjects treated with
G-CSF, the side-effects profile has been reported to be mild and reversible. Currently, G-CSF
is under investigation in clinical trials in Germany and the US that aim to enhance recovery
from strokes and heart attacks. In animal studies, G-CSF has been observed to improve
cognitive performance and to markedly reduce amyloid deposition in hippocampus and entorhinal
cortex in a mouse model of Alzheimer's Disease (AD). Since this drug is being used safely in
many people throughout the world, the investigators hypothesize that it will also be safe to
give to patients with Alzheimer's disease and that it may improve some aspects of memory and
thinking. The present pilot study has two goals or objectives: 1) to investigate the effects
of a five day schedule of Filgrastim administration on cognitive function and 2) to assess
its tolerability and safety in a small group (12 patients) with mild to moderate stage AD.
Patients who are eligible for the study will be randomly assigned to one of two groups (n=6
per group). One group will receive a five-day course of Filgrastim injections and the other
group of subjects will receive vehicle injections (solution without drug). At the end of the
first phase of the study (week 8), the groups will cross over to receive either vehicle or
Filgrastim as appropriate. In this way all subjects will have received the active medication
by the end of the study. After the study is finished the investigators should know whether or
not Filgrastim improves some aspects of thinking and memory. And the investigators should
know whether or not it is safe to give this medication to patients with Alzheimer's disease.
To ensure that the drug is safe, a Safety Monitoring Committee will oversee the entire study.
They will review all laboratory data, including complete blood counts, serum chemistry, EKGs
and adverse events.