Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of UB-311 in Mild Alzheimer's Disease (AD) Patients

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Biological: UB-311; Drug: Placebo

• Registration Number: NCT02551809
• Lead Sponsor: United Neuroscience Ltd.

Brief Summary

The purpose of this Phase IIa study is to determine whether the AD Immunotherapeutic Vaccine (UB-311), targeting the amyloid beta peptide (N-terminal amino acids, 1-14), is safe and immunogenic in mild AD patients. In addition, the efficacy profiles will be evaluated as the secondary endpoint.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-10
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-16
• Study Start: 2015-10
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Results First Submitted: 2019-12-24
• Results First Submitted QC: 2019-12-24
• Results First Posted: 2020-01-13
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-04
• Last Update Posted: 2020-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Diagnosis of mild Alzheimer's Disease
• Mini-Mental State Examination (MMSE) scores between 20 and 26 (inclusive)
• Clinical dementia rating (CDR) scores of 0.5 or 1
• Other inclusion criteria apply

Exclusion Criteria

• Clinically significant neurological disease other than Alzheimer's disease
• Major psychiatric disorder
• Severe systemic disease
• Serious adverse reactions to any vaccine
• Other exclusion criteria apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 priming doses followed by 2 boosters	Placebo	Subjects will receive 5 doses of UB-311 and 2 doses of placebo.
Placebo	Placebo	Subjects will receive 7 doses of placebo.
3 priming doses followed by 4 boosters	UB-311	Subjects will receive 7 doses of UB-311.
3 priming doses followed by 2 boosters	UB-311	Subjects will receive 5 doses of UB-311 and 2 doses of placebo.

Primary Outcome Measures

Name	Time	Method
Tolerability and Safety Profile of UB-311 Assessed Via Recording of Number of Participants With Adverse Events	78 weeks	Safety endpoints include local tolerability at the injection site, amyloid-related imaging abnormalities, vital signs, physical examination, 12-lead ECG, laboratory tests and other AEs and SAEs.

Trial Locations

Locations (4)

National Taiwan University Hospital (NTUH); 🇨🇳 Taipei, Taiwan

Taipei Veterans General Hospital (TVGH); 🇨🇳 Taipei, Taiwan

Linkou Chang Gung Memorial Hospital (LK-CGMH); 🇨🇳 Taoyuan, Taiwan

Kaohsiung Chang Gung Memorial Hospital (KS-CGMH); 🇨🇳 Kaohsiung, Taiwan