search
Back to results

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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CERE-110: Adeno-Associated Virus injection Surgery
Placebo Surgery
Sponsored by
Sangamo Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, Dementia, Memory loss, Cognitive impairment, Nerve growth factor, NGF, Neurotrophic factors, Gene therapy

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama
  • University of California, Los Angeles
  • University of California, San Diego
  • Georgetown University
  • Emory University
  • Mount Sinai School of Medicine
  • Duke University
  • Case Western Reserve University
  • Medical University of South Carolina
  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

CERE-110

Placebo

Arm Description

CERE-110: Adeno-Associated Virus Delivery of NGF

Placebo Surgery

Outcomes

Primary Outcome Measures

Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)

Secondary Outcome Measures

Neuropsychological Test Battery
Mini-Mental State Examination (MMSE)
Neuropsychiatric Inventory (NPI)
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)

Full Information

First Posted
April 3, 2009
Last Updated
December 14, 2020
Sponsor
Sangamo Therapeutics
Collaborators
Alzheimer's Disease Cooperative Study (ADCS)
search

1. Study Identification

Unique Protocol Identification Number
NCT00876863
Brief Title
Randomized, Controlled Study Evaluating CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease
Official Title
A Double-Blind, Placebo-Controlled (Sham Surgery), Randomized, Multicenter Study Evaluating CERE-110 Gene Delivery in Subjects With Mild to Moderate Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2008 (Actual)
Primary Completion Date
August 13, 2015 (Actual)
Study Completion Date
August 13, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sangamo Therapeutics
Collaborators
Alzheimer's Disease Cooperative Study (ADCS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's disease, Dementia, Memory loss, Cognitive impairment, Nerve growth factor, NGF, Neurotrophic factors, Gene therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CERE-110
Arm Type
Experimental
Arm Description
CERE-110: Adeno-Associated Virus Delivery of NGF
Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
Placebo Surgery
Intervention Type
Drug
Intervention Name(s)
CERE-110: Adeno-Associated Virus injection Surgery
Intervention Description
Injecting CERE-110 2.0 X 10^11 vg into brain during surgical procedure.
Intervention Type
Procedure
Intervention Name(s)
Placebo Surgery
Intervention Description
Placebo Surgery
Primary Outcome Measure Information:
Title
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
Time Frame
24 Months
Secondary Outcome Measure Information:
Title
Neuropsychological Test Battery
Time Frame
24 Months
Title
Mini-Mental State Examination (MMSE)
Time Frame
24 Months
Title
Neuropsychiatric Inventory (NPI)
Time Frame
24 Months
Title
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Time Frame
24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul S. Aisen, M.D.
Organizational Affiliation
Alzheimer's Disease Cooperative Study (ADCS)
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30325
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44120
Country
United States
Facility Name
Medical University of South Carolina
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29582053
Citation
Rafii MS, Tuszynski MH, Thomas RG, Barba D, Brewer JB, Rissman RA, Siffert J, Aisen PS; AAV2-NGF Study Team. Adeno-Associated Viral Vector (Serotype 2)-Nerve Growth Factor for Patients With Alzheimer Disease: A Randomized Clinical Trial. JAMA Neurol. 2018 Jul 1;75(7):834-841. doi: 10.1001/jamaneurol.2018.0233.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs