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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Alzheimer's Disease Cooperative Study (ADCS)

Information provided by (Responsible Party):

Ceregene

ClinicalTrials.gov Identifier:

NCT00876863

First received: April 3, 2009

Last updated: December 10, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 3, 2009

Last Updated Date

December 10, 2012

Start Date ^ICMJE

September 2009

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00876863 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Neuropsychological Test Battery [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Mini-Mental State Examination (MMSE) [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Neuropsychiatric Inventory (NPI) [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Alzheimer's Disease

Intervention ^ICMJE

Genetic: CERE-110: Adeno-Associated Virus Delivery of NGF
CERE-110 2.0 X 10^11 vg
Procedure: Placebo Surgery
Placebo Surgery

Study Arm (s)

Experimental: CERE-110
CERE-110: Adeno-Associated Virus Delivery of NGF

Intervention: Genetic: CERE-110: Adeno-Associated Virus Delivery of NGF
Sham Comparator: Placebo
Placebo Surgery

Intervention: Procedure: Placebo Surgery

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2014

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

55 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00876863

Other Study ID Numbers ^ICMJE

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

Has Data Monitoring Committee

Yes

Responsible Party

Ceregene

Study Sponsor ^ICMJE

Ceregene

Collaborators ^ICMJE

Alzheimer's Disease Cooperative Study (ADCS)

Investigators ^ICMJE

Study Director:

Paul S. Aisen, M.D.

Alzheimer's Disease Cooperative Study (ADCS)

Information Provided By

Ceregene

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top