This trial is active, not recruiting.

Condition alzheimer's disease
Treatments cere-110: adeno-associated virus delivery of ngf, placebo surgery
Phase phase 2
Sponsor Ceregene
Collaborator Alzheimer's Disease Cooperative Study (ADCS)
Start date September 2009
End date December 2014
Trial size 50 participants
Trial identifier NCT00876863, CERE-110-03, NIH Grant 1R01AG030048-01A1


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
CERE-110: Adeno-Associated Virus Delivery of NGF
cere-110: adeno-associated virus delivery of ngf
CERE-110 2.0 X 10^11 vg
(Sham Comparator)
Placebo Surgery
placebo surgery
Placebo Surgery

Primary Outcomes

Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
time frame: 24 Months

Secondary Outcomes

Neuropsychological Test Battery
time frame: 24 Months
Mini-Mental State Examination (MMSE)
time frame: 24 Months
Neuropsychiatric Inventory (NPI)
time frame: 24 Months
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
time frame: 24 Months

Eligibility Criteria

Male or female participants from 55 years up to 80 years old.

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

Additional Information

Official title A Double-Blind, Placebo-Controlled (Sham Surgery), Randomized, Multicenter Study Evaluating CERE-110 Gene Delivery in Subjects With Mild to Moderate Alzheimer's Disease
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Ceregene.