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CERE-110: Adeno-Associated Virus Surgery

Phase 2

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

Target and mechanism

ModalityGene therapy

Also known as CERE-110: Adeno-Associated Virus injection Surgery

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 that was studied for the treatment of mild to moderate Alzheimer's disease. It was delivered by stereotactic injection into the brain during a surgical procedure. The program is in Phase 2 development and is not approved for any indication.

Who is developing CERE-110?

CERE-110 is being developed by Sangamo Therapeutics, Inc., which trades on the Nasdaq under the ticker SGMO. Sangamo is the sponsor of the clinical program for this gene therapy candidate in Alzheimer's disease.

What phase is CERE-110 in?

CERE-110 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The program remains investigational and has not been approved by the FDA for Alzheimer's disease or any other indication.

What clinical trials is CERE-110 in?

CERE-110 was evaluated in one completed Phase 2 trial, NCT00876863, titled a randomized, controlled study of CERE-110 in subjects with mild to moderate Alzheimer's disease. The trial enrolled 49 participants in the United States, was randomized, double blind, and sham controlled, and included participants aged 55 years and older.

Is CERE-110 the same as CERE-110: Adeno-Associated Virus injection Surgery?

Yes. CERE-110 is also referred to as CERE-110: Adeno-Associated Virus injection Surgery. Both names describe the same gene therapy candidate developed by Sangamo Therapeutics for Alzheimer's disease, which is administered through an adeno-associated virus based surgical injection into the brain.