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CERE-110: Adeno-Associated Virus Delivery of NGF

Phase 1

Alzheimer's Disease | Gene Therapies | Neurology |Sangamo Therapeutics, Inc.|Trials Updated: Nov 10, 2022

CERE-110: Adeno-Associated Virus Delivery of NGF development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2004

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

CERE-110: Adeno-Associated Virus Delivery of NGF clinical trials

CERE-110: Adeno-Associated Virus Delivery of NGF · 1 trial · 1 indication

Phase 1 1
NCT00087789CERE-110 in Subjects With Mild to Moderate Alzheimer's DiseaseAlzheimer's Disease
COMPLETED10 Analytics
PHASE1COMPLETED
CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of three different doses of CERE-110 in subjects with mild to moderate Alzheimer's disease
24 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
CERE-110: Adeno-Associated Virus Delivery of NGFGENETICCERE-110 2.0 x 10\^10 vg, CERE-110 1.0 x 10\^11 vg, CERE-110 2.0 x 10\^11 vg
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Eligibility Criteria

Age Range50 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Alzheimer's disease as determined by NINCDS/ADRDA criteria. * Score of ≤ 4 on a modified Hachinski Ischemia Scale * Mini-Mental State Exam (MMSE) score in the range of 16 to 28, inclusive * No significant neurological or medical abnormalities contraindicating surgery, MRI/PET ...

Countries:United States
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Frequently asked questions about CERE-110: Adeno-Associated Virus Delivery of NGF

What is CERE-110 used for?

CERE-110 is an investigational gene therapy developed for Alzheimer's disease. It was studied in patients with mild to moderate Alzheimer's disease. CERE-110 is a gene therapy candidate that delivers nerve growth factor, or NGF, using an adeno-associated virus vector. It is not an approved treatment.

Who is developing CERE-110?

CERE-110 was developed by Sangamo Therapeutics, Inc., which trades under the ticker SGMOQ. The company sponsored the clinical development of this adeno-associated virus NGF gene therapy for Alzheimer's disease.

What phase is CERE-110 in?

CERE-110 is in Phase 1 development. One Phase 1 clinical trial has been completed, and no trials are currently active. CERE-110 is investigational and has not been approved by the FDA for Alzheimer's disease or any other indication.

What clinical trial was conducted for CERE-110?

CERE-110 was studied in a single completed Phase 1 trial, NCT00087789, titled CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease. The trial enrolled 10 participants aged 50 years and older in the United States. It was an uncontrolled, open-label study without randomization or blinding.

How does CERE-110 work?

CERE-110 is a gene therapy that uses an adeno-associated virus vector to deliver nerve growth factor, or NGF, to the brain. The approach is designed to provide sustained NGF expression in patients with Alzheimer's disease. CERE-110 was evaluated in a Phase 1 trial in mild to moderate Alzheimer's disease.