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CERE-110: Adeno-Associated Virus Surgery

Phase 2

Alzheimer's Disease | Small molecule | Neurology |Sangamo Therapeutics, Inc.|Last Updated: Dec 21, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindSHAM_CONTROLLEDDMC
Total Trials1
Total Enrollment49

FDA Designations

No designations recorded

Clinical trial landscape

CERE-110: Adeno-Associated Virus Surgery · 1 trial · 1 indication

Phase 2 1
NCT00876863Randomized, Controlled Study Evaluating CERE-110 in Subjects With Mild to Moderate Alzheimer's DiseaseAlzheimer's Disease
COMPLETED49 Analytics
PHASE2COMPLETED
Randomized, Controlled Study Evaluating CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Neuropsychological Test Battery
24 Months
Mini-Mental State Examination (MMSE)
24 Months
Neuropsychiatric Inventory (NPI)
24 Months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CERE-110EXPERIMENTALCERE-110: Adeno-Associated Virus Delivery of NGF
PlaceboSHAM_COMPARATORPlacebo Surgery

Interventions

NameTypeDescription
CERE-110: Adeno-Associated Virus injection SurgeryDRUGInjecting CERE-110 2.0 X 10\^11 vg into brain during surgical procedure.
Placebo SurgeryPROCEDUREPlacebo Surgery
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Eligibility Criteria

Age Range55 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites10

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 Cr...

Countries:United States
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Frequently asked questions about CERE-110: Adeno-Associated Virus Surgery

What is CERE-110 used for?

CERE-110 is an investigational gene therapy being studied for the treatment of mild to moderate Alzheimer's disease. It is administered via adeno-associated virus surgery, which involves delivering the therapy directly to the brain. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

What does CERE-110 target?

CERE-110 is designed to deliver a gene that produces nerve growth factor, a protein that supports the survival and function of cholinergic neurons, which are affected in Alzheimer's disease. By providing this growth factor, the therapy aims to slow the degeneration of these neurons and potentially preserve cognitive function.

Who makes CERE-110?

CERE-110 is being developed by Sangamo Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SGMO. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy for Alzheimer's disease.

What phase is CERE-110 in?

CERE-110 is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, sham-controlled study involving 49 participants with mild to moderate Alzheimer's disease. The drug remains investigational and is not yet approved for commercial use.

What clinical trials is CERE-110 in?

CERE-110 has been evaluated in a single completed Phase 2 clinical trial registered as NCT00876863. This study was a randomized, controlled trial conducted in the United States, enrolling 49 participants aged 55 years and older with mild to moderate Alzheimer's disease. The trial was double-blind and sham-controlled.

Is CERE-110 the same as adeno-associated virus surgery?

CERE-110 is an investigational gene therapy that is delivered through a surgical procedure involving adeno-associated virus. The term 'adeno-associated virus surgery' refers to the method of administration, not an alternative name for the drug itself. The therapy uses a viral vector to deliver the therapeutic gene to brain cells.