NsG0202: Encapsulated Cell Biodelivery of Nerve Growth Factor to Alzheimer´s Disease Patients

• Sponsor: NsGene A/S (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT01163825
• Collaborator: Karolinska Institutet (Other), Region Stockholm (Other)
• Enrollment: 6
• Location: 1
• Arms: 2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Drug: Nerve Growth Factor	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jan 1, 2008
• Anticipated Primary Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nerve Growth Factor Dose 1	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
Experimental: Nerve Growth Factor 2 Dose 2	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

Outcome Measures

Primary Outcome Measures

1. Adverse events [12 months]

Secondary Outcome Measures

1. Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) [12 months]

   Cognition using ADAS-Cog, neuropsychologic test battery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska University Hospital	Stockholm		Sweden	17176

Sponsors and Collaborators

• NsGene A/S
• Karolinska Institutet
• Region Stockholm

Investigators

• Principal Investigator: Maria E Jönhagen, MD PhD, Karolinska University Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Sponsor home page

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01163825
• Other Study ID Numbers: NsG0202-001
• First Posted: Jul 16, 2010
• Last Update Posted: Jul 16, 2010
• Last Verified: Jul 1, 2010

• Additional relevant MeSH terms: Alzheimer Disease; Mitogens

Study Results

No Results Posted as of Jul 16, 2010