Overview

This trial is active, not recruiting.

Condition alzheimer's disease
Treatment nerve growth factor
Phase phase 1
Sponsor NsGene A/S
Collaborator Karolinska Institutet
Start date January 2008
End date December 2011
Trial size 6 participants
Trial identifier NCT01163825, NsG0202-001

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Dose 1
nerve growth factor
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
(Experimental)
Dose 2
nerve growth factor
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

Primary Outcomes

Measure
Adverse events
time frame: 12 months

Secondary Outcomes

Measure
Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)
time frame: 12 months

Eligibility Criteria

Male or female participants from 50 years up to 80 years old.

Inclusion Criteria: 1. Age 50-80 years 2. All patients must fulfil the NINDNDS-ARDRA criteria of Alzheimer's disease. 3. The subject must have a score between 15-24 inclusive, on the mini-mental state examination (MMSE). 4. 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. 5. Informed consent must be obtained from the subject together with a close caregiver, in accordance with the requirements of the ethical committee. Exclusion Criteria: 1. A diagnosis of Schizophrenia, Schizo-affective disorder or paranoid disorder according to DSM IV without any suspicion cognitive decline. 2. Patients with the following co-existing medical conditions: 3. History of seizures. 4. Brain tumor including meningeoma. 5. Clinically significant hepatic, renal, pulmonary, metabolic or endocrine disturbances. 6. Clinically significant back pain. 7. Bleeding disorders. 8. Patients who, in the opinion of the investigator, are otherwise unsuitable for a trial of this type.

Additional Information

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
Principal investigator Maria E Jönhagen, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2010.
Information provided to ClinicalTrials.gov by NsGene A/S.