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

Alzheimer's Disease Clinical Trial

— NsG0202  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01163825
• Other study ID #: NsG0202-001
• Status: Active, not recruiting
• Phase: Phase 1
• First received: July 14, 2010
• Last updated: July 15, 2010
• Start date: January 2008

Study information

• Verified date: July 2010
• Source: NsGene A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
NsGene A/S	Karolinska Institutet, Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events		12 months	Yes
Secondary	Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)	Cognition using ADAS-Cog, neuropsychologic test battery	12 months	No

External Links

•   Sponsor home page