Status:
UNKNOWN
Encapsulated Cell Biodelivery of Nerve Growth Factor to Alzheimer´s Disease Patients
Lead Sponsor:
NsGene A/S
Collaborating Sponsors:
Karolinska Institutet
Region Stockholm
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-80 years
Phase:
PHASE1
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 s...
Eligibility Criteria
Inclusion
- Age 50-80 years
- All patients must fulfil the NINDNDS-ARDRA criteria of Alzheimer's disease.
- The subject must have a score between 15-24 inclusive, on the mini-mental state examination (MMSE).
- 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.
- Informed consent must be obtained from the subject together with a close caregiver, in accordance with the requirements of the ethical committee.
Exclusion
- A diagnosis of Schizophrenia, Schizo-affective disorder or paranoid disorder according to DSM IV without any suspicion cognitive decline.
- Patients with the following co-existing medical conditions:
- History of seizures.
- Brain tumor including meningeoma.
- Clinically significant hepatic, renal, pulmonary, metabolic or endocrine disturbances.
- Clinically significant back pain.
- Bleeding disorders.
- Patients who, in the opinion of the investigator, are otherwise unsuitable for a trial of this type.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01163825
Start Date
January 1 2008
Last Update
July 16 2010
Active Locations (1)
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1
Karolinska University Hospital
Stockholm, Sweden, 17176