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

December 14, 2020 updated by: Sangamo Therapeutics

A Double-Blind, Placebo-Controlled (Sham Surgery), Randomized, Multicenter Study Evaluating CERE-110 Gene Delivery in Subjects With Mild to Moderate Alzheimer's Disease

The purpose of this study is to evaluate the potential benefits of CERE-110 in the treatment of Alzheimer's disease. CERE-110 is an experimental drug that is designed to help nerve cells in the brain function better. CERE-110 uses a virus to transfer a gene that makes Nerve Growth Factor (NGF), a protein that may make nerve cells in the brain healthier and protect them from dying. The virus used in CERE-110 does not cause disease in people. CERE-110 has been carefully studied in laboratory animals and is in the early stages of being tested in people.

Fifty patients with mild to moderate Alzheimer's disease will participate in this study. Half of the study subjects will have CERE-110 injected into the brain during a surgical procedure, while the other half will undergo a "placebo" surgery where no medication will be injected. All study participants will be followed for at least two years after surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles
      • San Diego, California, United States, 92037
        • University of California, San Diego
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University
    • Georgia
      • Atlanta, Georgia, United States, 30325
        • Emory University
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
    • Ohio
      • Cleveland, Ohio, United States, 44120
        • Case Western Reserve University
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Medical University of South Carolina
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CERE-110
CERE-110: Adeno-Associated Virus Delivery of NGF
Drug: CERE-110: Adeno-Associated Virus injection Surgery
Injecting CERE-110 2.0 X 10^11 vg into brain during surgical procedure.
Sham Comparator: Placebo
Placebo Surgery
Procedure: Placebo Surgery
Placebo Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
Time Frame: 24 Months
24 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Neuropsychological Test Battery
Time Frame: 24 Months
24 Months
Mini-Mental State Examination (MMSE)
Time Frame: 24 Months
24 Months
Neuropsychiatric Inventory (NPI)
Time Frame: 24 Months
24 Months
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Time Frame: 24 Months
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sangamo Therapeutics

Collaborators

Alzheimer's Disease Cooperative Study (ADCS)

Investigators

  • Study Director: Paul S. Aisen, M.D., Alzheimer's Disease Cooperative Study (ADCS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2008

Primary Completion (Actual)

August 13, 2015

Study Completion (Actual)

August 13, 2015

Study Registration Dates

First Submitted

April 3, 2009

First Submitted That Met QC Criteria

April 3, 2009

First Posted (Estimate)

April 7, 2009

Study Record Updates

Last Update Posted (Actual)

December 21, 2020

Last Update Submitted That Met QC Criteria

December 14, 2020

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CERE-110-03
  • NIH Grant 1R01AG030048-01A1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer's Disease

Clinical Trials on CERE-110: Adeno-Associated Virus injection Surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe