Observational Study to Monitor Long-term Immunogenicity and Efficacy of UB 311 Vaccine in Subjects With Alzheimer's Disease

NCT01189084 | Completed

• 1 other identifier: UBI Protocol V118-obs
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this observational study is to determine whether the vaccine (UB 311), targeting the N-terminal amino acids (1-14) of the amyloid beta peptide, has long-term immunogenicity and efficacy in individuals diagnosed with mild or moderate Alzheimer's disease (AD) who previously received UB 311-treatment. Amyloid beta was selected as the target antigen based on supporting evidence of the hypothesis that places the accumulation of amyloid beta at the initiating step of AD.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease; amyloid beta; vaccine

Outcome Measures

Primary Outcomes (1)

• Immunogenicity

  Long-term followup to week 48

  24 weeks

Secondary Outcomes (1)

• Efficacy

  24 weeks

Study Arms (1)

Observational immunotherapy follow-up

Biological: Observational

Interventions

Observational BIOLOGICAL

Measure anti-Amyloid-beta antibody in serum during 24-26 weeks extension period to 48 weeks (after first vaccine treatment).

Observational immunotherapy follow-up

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Enrolled subjects who received UB 311-treatment in the initial UBI Protocol V118 (Protocol V118-AD) Phase I trial are eligible for continued follow-up to week 48

You may qualify if:

• Individuals with mild to moderate Alzheimer's disease who received three (3) injections of UB 311 in the initial Phase I V118-AD trial

You may not qualify if:

• Individuals with Alzheimer's disease who are currently on prohibited medications, have severe or uncontrolled systemic disease, or are unable or unwilling to comply with study protocol requirements.

Sponsors & Collaborators

• United Biomedical: lead
• Taipei Veterans General Hospital, Taiwan: collaborator
• National Taiwan University Hospital: collaborator

Study Sites (2)

National Taiwan University Hospital (NTUH)

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Related Publications (1)

• Wang CY, Finstad CL, Walfield AM, Sia C, Sokoll KK, Chang TY, Fang XD, Hung CH, Hutter-Paier B, Windisch M. Site-specific UBITh amyloid-beta vaccine for immunotherapy of Alzheimer's disease. Vaccine. 2007 Apr 20;25(16):3041-52. doi: 10.1016/j.vaccine.2007.01.031. Epub 2007 Jan 19.

  PMID: 17287052 BACKGROUND

Related Links

• ClinicalTrials.gov Identifier: NCT00965588

Biospecimen

Retention: SAMPLES WITHOUT DNA

Periodic blood samples collected for serum and measurement of anti-Amyloid-beta antibody levels.

MeSH Terms

Conditions

Alzheimer Disease; Plaque, Amyloid

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Pei-Ning Wang, M.D.

  Taipei Veterans General Hospital (TVGH)

  PRINCIPAL INVESTIGATOR

• Ming-Jang Chiu, M.D.

  National Taiwan University Hospital (NTUH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 24, 2010
• First Posted: August 26, 2010
• Study Start: April 1, 2010
• Study Completion: July 1, 2011
• Last Updated: July 13, 2011

Record last verified: 2011-07

Locations

TW (2)