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

• Sponsor: Sangamo Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00876863
• Collaborator: Alzheimer's Disease Cooperative Study (ADCS) (Other)
• Enrollment: 49
• Locations: 10
• Arms: 2
• Actual Duration (Months): 81.3
• Patients Per Site: 4.9
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Drug: CERE-110: Adeno-Associated Virus injection Surgery; Procedure: Placebo Surgery	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Aug 13, 2015
• Actual Study Completion Date: Aug 13, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [24 Months]

Secondary Outcome Measures

1. Neuropsychological Test Battery [24 Months]

2. Mini-Mental State Examination (MMSE) [24 Months]

3. Neuropsychiatric Inventory (NPI) [24 Months]

4. Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [24 Months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35294
2	University of California, Los Angeles	Los Angeles	California	United States	90095
3	University of California, San Diego	San Diego	California	United States	92037
4	Georgetown University	Washington	District of Columbia	United States	20007
5	Emory University	Atlanta	Georgia	United States	30325
6	Mount Sinai School of Medicine	New York	New York	United States	10029
7	Duke University	Durham	North Carolina	United States	27710
8	Case Western Reserve University	Cleveland	Ohio	United States	44120
9	Medical University of South Carolina	North Charleston	South Carolina	United States	29406
10	University of Utah	Salt Lake City	Utah	United States	84108

Sponsors and Collaborators

• Sangamo Therapeutics
• Alzheimer's Disease Cooperative Study (ADCS)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sangamo Therapeutics
• ClinicalTrials.gov Identifier: NCT00876863
• Other Study ID Numbers: CERE-110-03; NIH Grant 1R01AG030048-01A1
• First Posted: Apr 7, 2009
• Last Update Posted: Dec 21, 2020
• Last Verified: Jan 1, 2017

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sangamo Therapeutics: Alzheimer's disease; Dementia; Memory loss; Cognitive impairment; Nerve growth factor; NGF; Neurotrophic factors; Gene therapy
• Additional relevant MeSH terms: Alzheimer Disease

Study Results

No Results Posted as of Dec 21, 2020