Randomized, Controlled Study Evaluating CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease

Study Overview
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Brief Summary
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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.

Official Title
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A Double-Blind, Placebo-Controlled (Sham Surgery), Randomized, Multicenter Study Evaluating CERE-110 Gene Delivery in Subjects With Mild to Moderate Alzheimer's Disease

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: CERE-110: Adeno-Associated Virus injection Surgery
* Procedure: Placebo Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CERE-110<br>CERE-110: Adeno-Associated Virus Delivery of NGF | Drug: CERE-110: Adeno-Associated Virus injection Surgery<br>* Injecting CERE-110 2.0 X 10^11 vg into brain during surgical procedure.<br>|
| Sham Comparator: Placebo<br>Placebo Surgery | Procedure: Placebo Surgery<br>* Placebo Surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) |  | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease, Dementia, Memory loss, Cognitive impairment, Nerve growth factor, NGF, Neurotrophic factors, Gene therapy