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

NCT01163825 | Unknown Phase 1 DMC

• 1 other identifier: NsG0202-001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Adverse events

  12 months

Secondary Outcomes (1)

• Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)

  12 months

Study Arms (2)

Nerve Growth Factor

EXPERIMENTAL

Dose 1

Drug: Nerve Growth Factor

Nerve Growth Factor 2

EXPERIMENTAL

Dose 2

Drug: Nerve Growth Factor

Interventions

Nerve Growth Factor DRUG

Encapsulated cell biodelivery of Nerve Growth Factor (NGF) to the basal forebrain nuclei of the brain by multiple implantable devices housing NGF-secreting human cells

Nerve Growth Factor; Nerve Growth Factor 2

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50-80 years
• All patients must fulfil the NINDNDS-ARDRA criteria of Alzheimer's disease.
• The subject must have a score between 15-24 inclusive, on the mini-mental state examination (MMSE).
• The subject must have a caregiver who is able and committed to assist the subject to comply with the trial protocol, and who is willing to provide the information required at assessment interviews.
• Informed consent must be obtained from the subject together with a close caregiver, in accordance with the requirements of the ethical committee.

You may not qualify if:

• A diagnosis of Schizophrenia, Schizo-affective disorder or paranoid disorder according to DSM IV without any suspicion cognitive decline.
• Patients with the following co-existing medical conditions:
• History of seizures.
• Brain tumor including meningeoma.
• Clinically significant hepatic, renal, pulmonary, metabolic or endocrine disturbances.
• Clinically significant back pain.
• Bleeding disorders.
• Patients who, in the opinion of the investigator, are otherwise unsuitable for a trial of this type.

Sponsors & Collaborators

• NsGene A/S: lead
• Karolinska Institutet: collaborator
• Region Stockholm: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (3)

• 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.

  PMID: 32375872 DERIVED

• 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.

  PMID: 27389402 DERIVED

• 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.

  PMID: 22655593 DERIVED

Related Links

• Sponsor home page

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Nerve Growth Factor

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Nerve Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Nerve Tissue Proteins; Biological Factors

Study Officials

• Maria E Jönhagen, MD PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 16, 2010
• Study Start: January 1, 2008
• Primary Completion: December 1, 2011
• Last Updated: July 16, 2010

Record last verified: 2010-07

Locations

SE (1)