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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by NsGene A/S.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Karolinska Institutet
Stockholm County Council, Sweden
Information provided by:
NsGene A/S
ClinicalTrials.gov Identifier:
NCT01163825
First received: July 14, 2010
Last updated: July 15, 2010
Last verified: July 2010
  Purpose

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 Intervention Phase
Alzheimer's Disease
Drug: Nerve Growth Factor
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by NsGene A/S:

Primary Outcome Measures:
  • Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Cognition using ADAS-Cog, neuropsychologic test battery


Enrollment: 6
Study Start Date: January 2008
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01163825

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

Additional Information:
No publications provided by NsGene A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lars U. Wahlberg, MD, PhD, Exec.VP, COO, CMO, NsGene A/S
ClinicalTrials.gov Identifier: NCT01163825     History of Changes
Other Study ID Numbers: NsG0202-001
Study First Received: July 14, 2010
Last Updated: July 15, 2010
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014