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NCT Number: NCT00876863

Randomized, Controlled Study Evaluating CERE-110 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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Genetic Diseases, Inborn Hereditary Sensory and Autonomic Neuropathies Heredodegenerative Disorders, Nervous System Memory Disorders Mental Disorders Nervous System Diseases Nervous System Malformations Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Signs and Symptoms Tauopathies

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alabama, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CERE-110: Adeno-Associated Virus injection Surgery

Drug

Injecting CERE-110 2.0 X 10^11 vg into brain during surgical procedure.

Placebo surgery

Procedure

Placebo Surgery

Primary outcomes

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

    Time frame: 24 Months

Secondary outcomes

  1. Neuropsychological Test Battery

    Time frame: 24 Months

  2. Mini-Mental State Examination (MMSE)

    Time frame: 24 Months

  3. Neuropsychiatric Inventory (NPI)

    Time frame: 24 Months

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

    Time frame: 24 Months

Sponsors and collaborators

Lead sponsor

Sangamo Therapeutics

Industry

Collaborators

  • Alzheimer's Disease Cooperative Study (ADCS)

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Apr 7, 2009
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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