Randomized, Controlled Study Evaluating CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease

Plain-language summary

This study evaluated CERE-110 gene therapy in people with mild to moderate Alzheimer's disease. The treatment delivers the nerve growth factor gene into the brain surgically using an adeno-associated virus (AAV) vector, and was compared against placebo surgery. It was carried out as a Phase 2 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Sangamo Therapeutics

Intervention

CERE-110: Adeno-Associated Virus injection Surgery, Placebo Surgery

Start date

11/1/2008

Estimated completion

8/13/2015

Countries

United States

Related genes

Locations

• Birmingham, United States
• Los Angeles, United States
• San Diego, United States
• Washington D.C., United States
• Atlanta, United States
• New York, United States
• Durham, United States
• Cleveland, United States
• North Charleston, United States
• Salt Lake City, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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