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

July 15, 2010 updated by: NsGene A/S

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17176
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)
Time Frame: 12 months
Cognition using ADAS-Cog, neuropsychologic test battery
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NsGene A/S

Collaborators

Karolinska Institutet
Region Stockholm

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

July 14, 2010

First Submitted That Met QC Criteria

July 15, 2010

First Posted (Estimate)

July 16, 2010

Study Record Updates

Last Update Posted (Estimate)

July 16, 2010

Last Update Submitted That Met QC Criteria

July 15, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NsG0202-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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