Alzheimer's Disease
Conditions
Keywords
Alzheimer's disease, Dementia, Memory loss, Cognitive impairment, Nerve growth factor, NGF, Neurotrophic factors, Gene therapy
Brief summary
The purpose of this study is to evaluate the potential benefits of CERE-110 in the treatment of Alzheimer's disease. CERE-110 is an experimental drug that is designed to help nerve cells in the brain function better. CERE-110 uses a virus to transfer a gene that makes Nerve Growth Factor (NGF), a protein that may make nerve cells in the brain healthier and protect them from dying. The virus used in CERE-110 does not cause disease in people. CERE-110 has been carefully studied in laboratory animals and is in the early stages of being tested in people. Fifty patients with mild to moderate Alzheimer's disease will participate in this study. Half of the study subjects will have CERE-110 injected into the brain during a surgical procedure, while the other half will undergo a placebo surgery where no medication will be injected. All study participants will be followed for at least two years after surgery.
Interventions
DRUGCERE-110: Adeno-Associated Virus injection Surgery
Injecting CERE-110 2.0 X 10\^11 vg into brain during surgical procedure.
PROCEDUREPlacebo Surgery
Placebo Surgery
Sponsors
Alzheimer's Disease Cooperative Study (ADCS)
Sangamo Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of mild to moderate Alzheimer's disease * Approved medications for Alzheimer's disease may be taken if the dose has been stable for 3 months * A study partner who can attend all study visits * Good general health * Medically able to undergo neurosurgery
Exclusion criteria
* Significant neurological disease other than Alzheimer's disease * Significant depression or other psychiatric disorder * Unstable medical conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) | 24 Months |
Secondary
| Measure | Time frame |
|---|---|
| Neuropsychological Test Battery | 24 Months |
| Mini-Mental State Examination (MMSE) | 24 Months |
| Neuropsychiatric Inventory (NPI) | 24 Months |
| Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) | 24 Months |
Countries
United States
Outcome results
None listed