- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00087789
CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease
November 8, 2022 updated by: Sangamo Therapeutics
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
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
-
-
California
-
San Diego, California, United States, 92037
- University of California San Diego
-
-
Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
-
-
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
50 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability of three different doses of CERE-110 in subjects with mild to moderate Alzheimer's disease
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
June 1, 2004
Primary Completion (ACTUAL)
May 1, 2010
Study Completion (ACTUAL)
May 1, 2010
Study Registration Dates
First Submitted
July 13, 2004
First Submitted That Met QC Criteria
July 15, 2004
First Posted (ESTIMATE)
July 16, 2004
Study Record Updates
Last Update Posted (ACTUAL)
November 10, 2022
Last Update Submitted That Met QC Criteria
November 8, 2022
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CERE-110-01
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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