Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00087789
Previous Study | Return to List | Next Study

CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease

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: NCT00087789
Recruitment Status : Completed
First Posted : July 16, 2004
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Sangamo Therapeutics ( Ceregene )

Tracking Information
First Submitted Date  ICMJE July 13, 2004
First Posted Date  ICMJE July 16, 2004
Last Update Posted Date October 31, 2016
Study Start Date  ICMJE June 2004
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2008)
Safety and tolerability of three different doses of CERE-110 in subjects with mild to moderate Alzheimer's disease [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00087789 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease
Official Title  ICMJE A Phase I, Dose-Escalating Study to Assess the Safety and Tolerability of CERE-110 [Adeno-Associated Virus (AAV)-Based Vector-Mediated Delivery of Beta-Nerve Growth Factor (NGF)] in Subjects With Mild to Moderate Alzheimer's Disease
Brief Summary This is a Phase I clinical study to assess the safety, tolerability and biologic activity of in vivo AAV-mediated delivery of CERE-110. Up to 12 subjects will receive open label CERE-110 in dose-escalating fashion. All subjects will receive bilateral, stereotactic injections of CERE-110 for a total of four (Dose A and B) and six (Dose C) injections to target the basal forebrain region of the brain containing the nucleus basalis of Meynert (NBM). All study participants will be observed for a 24-month period and then followed annually.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE Genetic: CERE-110: Adeno-Associated Virus Delivery of NGF
CERE-110 2.0 x 10^10 vg, CERE-110 1.0 x 10^11 vg, CERE-110 2.0 x 10^11 vg
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2008)
10
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
6
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Alzheimer's disease as determined by NINCDS/ADRDA criteria.
  • Score of ≤ 4 on a modified Hachinski Ischemia Scale
  • Mini-Mental State Exam (MMSE) score in the range of 16 to 28, inclusive
  • No significant neurological or medical abnormalities contraindicating surgery, MRI/PET imaging or study participation
  • Subjects stable on standard-of-care medications (i.e., acetylcholinesterase inhibitors) for Alzheimer's disease for 3 months prior to entry
  • A Hamilton Depression Scale score of ≤ 12 on a 17-item scale and no history of major depressive episode within the last 2 years
  • A score of < 15 on the Beck Depression Inventory
  • Adequate visual and auditory acuity to allow neuropsychological testing
  • Good health with no clinically significant medical or psychological conditions
  • An MRI of the head at screen that is negative for evidence of infection, tumor, infarction or other focal (e.g., subdural hematoma) or generalized lesions(e.g., v hydrocephalus) and without clinical symptoms suggestive of intervening neurological disease
  • Normal serum B12, thyroid function tests, and negative syphilis antibody test
  • The informed consent document must be signed by both:

a competent and willing subject, and a surrogate identified by the participant, or a legally authorized power of attorney for Health Care, or a family member

Exclusion Criteria:

  • History of cancer within the last five years, except superficial basal or squamous cell skin cancer or cervical carcinoma in situ
  • History of alcohol abuse or dependence within the last two years
  • Liver serum transaminases (AST and/or ALT) > 5 times the upper limit of normal; total and/or direct bilirubin > 1.5 mg/dL, hemoglobin < 9mg/dL; PT and PTT > 2 times the upper limit of normal; creatinine clearance < 30 mL/min; positive serology for HBV or HCV; absolute neutrophil count < 1,500 cells/mm3 and a platelet count < 100,000/mm3
  • Any significant systemic illness, unstable or severe medical condition(s) that could put the subject at risk during the study, interfere with outcome measures or affect compliance with the protocol procedures
  • Centrally active beta-blockers, anti-Parkinsonian medications, psychostimulants, antipsychotics, neuroleptics, or narcotic analgesics, long-acting benzodiazepines or barbiturates, hypertensive agents with a CNS effect, short-acting anxiolytics or sedative hypnotics more frequently than two times per week within 14 days of screening, herbal products for Alzheimer's disease, antidepressants with significant cholinergic side effects (e.g., tricyclics), initiation or change in dose of standard treatment for Alzheimer's disease
  • Other medication with significant cholinergic or anticholinergic side effects
  • Warfarin (coumadin), nonsteroidal anti-inflammatory drugs, aspirin, Prozac, or Ginkgo biloba within 14 days of surgery
  • Subjects who have received investigational agents or been exposed to investigational devices for 30 days prior to enrollment
  • Subjects with a history of receiving gene transfer products of any kind
  • Subjects who cannot undergo MRI or PET screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00087789
Other Study ID Numbers  ICMJE CERE-110-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sangamo Therapeutics ( Ceregene )
Study Sponsor  ICMJE Ceregene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Joao Siffert, M.D. Ceregene
PRS Account Sangamo Therapeutics
Verification Date October 2016

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