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CERE-110: Adeno-Associated Virus Surgery

Phase 2

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

CERE-110: Adeno-Associated Virus Surgery target and mechanism

ModalityGene Therapies

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

CERE-110: Adeno-Associated Virus Surgery clinical trials

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?

CERE-110 is an investigational gene therapy developed by Sangamo Therapeutics, Inc. (ticker SGMOQ) for Alzheimer's Disease. It is given as a surgical injection and was studied in a Phase 2 clinical trial. CERE-110 is also known as CERE-110: Adeno-Associated Virus injection Surgery.

What is CERE-110 used for in Alzheimer's Disease?

CERE-110 was developed for the treatment of mild to moderate Alzheimer's Disease. It is a gene therapy administered through a surgical injection procedure. Its clinical development centered on a single Phase 2 study in subjects with mild to moderate Alzheimer's Disease conducted in the United States.

Who makes CERE-110?

CERE-110 is developed by Sangamo Therapeutics, Inc., which trades under the ticker SGMOQ. The company sponsored the clinical development of this gene therapy candidate for Alzheimer's Disease.

What phase is CERE-110 in?

CERE-110 reached Phase 2 clinical development. It is an investigational gene therapy and is not described as approved. The Phase 2 program has been completed, and there are no active trials of CERE-110.

What clinical trials is CERE-110 in?

CERE-110 was studied in one completed Phase 2 trial, NCT00876863, titled a randomized, controlled study evaluating 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: Adeno-Associated Virus injection Surgery is another name for CERE-110. Both refer to the same investigational gene therapy developed by Sangamo Therapeutics, Inc. for Alzheimer's Disease, which was evaluated in the completed Phase 2 trial NCT00876863.