Encapsulated Cell Biodelivery of Nerve Growth Factor to Alzheimer´s Disease Patients

Summary

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).

Timeline

Start

2008-01

Primary completion

2011-12

Completion

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Publications

• Machado A, Ferreira D, Grothe MJ, Eyjolfsdottir H, Almqvist PM, Cavallin L, Lind G, Linderoth B, Seiger A, Teipel S, Wahlberg LU, Wahlund LO, Westman E, Eriksdotter M; Alzheimer's Disease Neuroimaging Initiative. The cholinergic system in subtypes of Alzheimer's disease: an in vivo longitudinal MRI study. Alzheimers Res Ther. 2020 May 6;12(1):51. doi: 10.1186/s13195-020-00620-7.
• Eyjolfsdottir H, Eriksdotter M, Linderoth B, Lind G, Juliusson B, Kusk P, Almkvist O, Andreasen N, Blennow K, Ferreira D, Westman E, Nennesmo I, Karami A, Darreh-Shori T, Kadir A, Nordberg A, Sundstrom E, Wahlund LO, Wall A, Wiberg M, Winblad B, Seiger A, Wahlberg L, Almqvist P. Targeted delivery of nerve growth factor to the cholinergic basal forebrain of Alzheimer's disease patients: application of a second-generation encapsulated cell biodelivery device. Alzheimers Res Ther. 2016 Jul 7;8(1):30. doi: 10.1186/s13195-016-0195-9.
• Wahlberg LU, Lind G, Almqvist PM, Kusk P, Tornoe J, Juliusson B, Soderman M, Sellden E, Seiger A, Eriksdotter-Jonhagen M, Linderoth B. Targeted delivery of nerve growth factor via encapsulated cell biodelivery in Alzheimer disease: a technology platform for restorative neurosurgery. J Neurosurg. 2012 Aug;117(2):340-7. doi: 10.3171/2012.2.JNS11714. Epub 2012 Jun 1.

Drugs

Indications