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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01163825
Recruitment Status : Unknown
Verified July 2010 by NsGene A/S.
Recruitment status was:  Active, not recruiting
First Posted : July 16, 2010
Last Update Posted : July 16, 2010
Sponsor:
Collaborators:
Karolinska Institutet
Region Stockholm
Information provided by:
NsGene A/S

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : January 2008
Estimated Primary Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Adverse events [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) [ Time Frame: 12 months ]
    Cognition using ADAS-Cog, neuropsychologic test battery


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163825


Locations
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Sweden
Karolinska University Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
NsGene A/S
Karolinska Institutet
Region Stockholm
Investigators
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Principal Investigator: Maria E Jönhagen, MD PhD Karolinska University Hospital
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lars U. Wahlberg, MD, PhD, Exec.VP, COO, CMO, NsGene A/S
ClinicalTrials.gov Identifier: NCT01163825    
Other Study ID Numbers: NsG0202-001
First Posted: July 16, 2010    Key Record Dates
Last Update Posted: July 16, 2010
Last Verified: July 2010
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
 Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action