Alzheimer's Disease Clinical Trial
Official title:
An Open Label, Dose-Escalation Study of Encapsulated Cell Biodelivery of Nerve Growth Factor to the Cholinergic Basal Forebrain of Alzheimer´s Disease Patients
Cholinergic neurons in the basal forebrain project widely to the cerebral cortex and
hippocampus. These neurons depend on nerve growth factor (NGF) from their target areas for
survival. Impaired NGF supply is part of the Alzheimer's disease (AD) pathology, and the
degeneration of these neurons correlates with the cognitive decline in these patients. The
objective of encapsulated cell biodelivery (ECB) is to maintain normal levels of NGF to
support cholinergic function. NsGene's NGF secreting ECB device (NsG0202) combines the
potential benefits of targeted gene therapy with the safety of a retrievable implantable
device.
The study is an open label, single centre, 12-month, dose-escalation phase Ib study in
patients with mild to moderate AD. The primary objective is safety and tolerability, while
secondary outcomes measure include cognition, behaviour, neuropsychology, activities of
daily living (ADL), positron emission tomography (PET) imaging and electroencephalography
(EEG).
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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