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OpenTrials
Completed

NCT Number: NCT00965588

Study to Evaluate Safety, Tolerability and Immunogenicity of Vaccine (UB 311) in Subjects With Alzheimer's Disease

The purpose of this Phase I study is to determine whether the vaccine (UB 311), targeting the amyloid beta peptide (N-terminal amino acids, 1-14), is safe and immunogenic in patients diagnosed with mild or moderate Alzheimer's disease (AD). 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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Amyloid Tauopathies

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Taiwan University Hospital (NTUH), Taipei, Taiwan

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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
  • Mini-Mental State Examination (MMSE) 15-25
  • Other inclusion criteria apply

Exclusion criteria

  • Major psychiatric disorder
  • Severe systemic disease
  • Serious adverse reactions to any vaccine
  • Other exclusion criteria apply

Treatment and study plan

UB 311

Biological

Single liquid dose by intramuscular route at weeks 0, 4, 12.

Primary outcomes

  1. To evaluate safety and tolerability of the vaccine (UB 311).

    Time frame: Screen, treatment & follow-up: 28-30 weeks

Secondary outcomes

  1. To evaluate immunogenicity [and efficacy] of the vaccine (UB 311).

    Time frame: Screen, treatment & follow-up: 28-30 weeks

Sponsors and collaborators

Lead sponsor

United Biomedical

Industry

Collaborators

  • National Taiwan University Hospital
  • Taipei Veterans General Hospital, Taiwan

Registry information

Official study title

A Phase I, Open-Label Study to Evaluate the Safety, Tolerability and Immunogenicity of the UBITh AD Immunotherapeutic Vaccine (UB 311) in Patients With Mild to Moderate Alzheimer's Disease

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 25, 2009
Registry last updated
Aug 23, 2011

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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