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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
History of Changes

July 14, 2010
July 15, 2010
January 2008
December 2011   (final data collection date for primary outcome measure)
Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01163825 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Encapsulated Cell Biodelivery of Nerve Growth Factor to Alzheimer´s Disease Patients
An Open Label, Dose-Escalation Study of Encapsulated Cell Biodelivery of Nerve Growth Factor to the Cholinergic Basal Forebrain of Alzheimer´s Disease Patients

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).
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Alzheimer's Disease
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
    Dose 1
    Intervention: Drug: Nerve Growth Factor
  • Experimental: Nerve Growth Factor 2
    Dose 2
    Intervention: Drug: Nerve Growth Factor
Wahlberg LU, Lind G, Almqvist PM, Kusk P, Tornøe J, Juliusson B, Söderman M, Selldén E, Seiger Å, Eriksdotter-Jönhagen M, Linderoth B. Targeted delivery of nerve growth factor via encapsulated cell biodelivery in Alzheimer disease: a technology platform for restorative neurosurgery. J Neurosurg. 2012 Aug;117(2):340-7. Epub 2012 Jun 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
6
Not Provided
December 2011   (final data collection date for primary outcome measure)

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.
Both
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01163825
NsG0202-001
Yes
Lars U. Wahlberg, MD, PhD, Exec.VP, COO, CMO, NsGene A/S
NsGene A/S
  • Karolinska Institutet
  • Stockholm County Council, Sweden
Principal Investigator: Maria E Jönhagen, MD PhD Karolinska University Hospital
NsGene A/S
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP