Gene Therapy for Alzheimer's Disease Clinical Trial

NCT00017940 | Completed Phase 1

• 1 other identifier: IA0029
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase I clinical trial is the first step in testing gene therapy. This study is called a "Safety/Toxicity" study by the Food and Drug Administration, and primarily aims to determine whether the experimental protocol is safe for humans. It will determine whether the study procedure causes side effects in humans, and may also give us a preliminary sense of whether this will be effective in combating Alzheimer's disease in humans.

Conditions

Alzheimer Disease

Keywords

Gene Therapy

Interventions

Human Nerve Growth Factor GENETIC

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* Neurologist certified diagnosis of probable Alzheimer's disease * Early stage of Alzheimer's disease (generally within three years of onset) * Normal speaking ability and normal ability to understand * Ability to understand the potential risks of participation in this study * Willing to visit the San Diego area and be available for many visits in the first year * Willing to discontinue use of drugs Cognex, Aricept, Exelon, or Reminyl for the first 18 months of the trial

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The Shiley Family Trust: lead
• Institute for the Study of Aging (ISOA): collaborator
• University of California, San Diego: collaborator

Study Sites (1)

University of California, San Diego, ADRC

La Jolla, California, 92037, United States

Location

Related Publications (3)

• Smith DE, Roberts J, Gage FH, Tuszynski MH. Age-associated neuronal atrophy occurs in the primate brain and is reversible by growth factor gene therapy. Proc Natl Acad Sci U S A. 1999 Sep 14;96(19):10893-8. doi: 10.1073/pnas.96.19.10893.

  PMID: 10485922 BACKGROUND

• Conner JM, Darracq MA, Roberts J, Tuszynski MH. Nontropic actions of neurotrophins: subcortical nerve growth factor gene delivery reverses age-related degeneration of primate cortical cholinergic innervation. Proc Natl Acad Sci U S A. 2001 Feb 13;98(4):1941-6. doi: 10.1073/pnas.98.4.1941.

  PMID: 11172055 BACKGROUND

• Tuszynski MH, Thal L, Pay M, Salmon DP, U HS, Bakay R, Patel P, Blesch A, Vahlsing HL, Ho G, Tong G, Potkin SG, Fallon J, Hansen L, Mufson EJ, Kordower JH, Gall C, Conner J. A phase 1 clinical trial of nerve growth factor gene therapy for Alzheimer disease. Nat Med. 2005 May;11(5):551-5. doi: 10.1038/nm1239. Epub 2005 Apr 24.

  PMID: 15852017 RESULT

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Mark Tuszynski, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 20, 2001
• First Posted: June 22, 2001
• Primary Completion: November 1, 2003
• Study Completion: November 1, 2003
• Last Updated: December 11, 2009

Record last verified: 2005-07

Locations

US (1)