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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02551809
Recruitment Status : Completed
First Posted : September 16, 2015
Results First Posted : January 13, 2020
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
United Neuroscience Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Alzheimer's Disease
Interventions Biological: UB-311
Drug: Placebo
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 3 Priming Doses Followed by 4 Boosters 3 Priming Doses Followed by 2 Boosters Placebo
Hide Arm/Group Description

Subjects will receive 7 doses of UB-311.

UB-311: Intramuscular injection

Subjects will receive 5 doses of UB-311 and 2 doses of placebo.

UB-311: Intramuscular injection

Placebo: Intramuscular injection

Subjects will receive 7 doses of placebo.

Placebo: Intramuscular injection

Period Title: Overall Study
Started 14 15 14
Completed 14 14 13
Not Completed 0 1 1
Arm/Group Title 3 Priming Doses Followed by 4 Boosters 3 Priming Doses Followed by 2 Boosters Placebo Total
Hide Arm/Group Description

Subjects will receive 7 doses of UB-311.

UB-311: Intramuscular injection

Subjects will receive 5 doses of UB-311 and 2 doses of placebo.

UB-311: Intramuscular injection

Placebo: Intramuscular injection

Subjects will receive 7 doses of placebo.

Placebo: Intramuscular injection

Total of all reporting groups
Overall Number of Baseline Participants 14 15 14 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 15 participants 14 participants 43 participants
73.4  (6.81) 72.5  (6.79) 72.0  (7.62) 72.6  (6.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 14 participants 43 participants
Female
11
  78.6%
10
  66.7%
11
  78.6%
32
  74.4%
Male
3
  21.4%
5
  33.3%
3
  21.4%
11
  25.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 14 participants 43 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
14
 100.0%
15
 100.0%
14
 100.0%
43
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
APOE4 carrier  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 14 participants 43 participants
10
  71.4%
12
  80.0%
13
  92.9%
35
  81.4%
1.Primary Outcome
Title Tolerability and Safety Profile of UB-311 Assessed Via Recording of Number of Participants With Adverse Events
Hide Description 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.
Time Frame 78 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 3 Priming Doses Followed by 4 Boosters 3 Priming Doses Followed by 2 Boosters Placebo
Hide Arm/Group Description:

Subjects will receive 7 doses of UB-311.

UB-311: Intramuscular injection

Subjects will receive 5 doses of UB-311 and 2 doses of placebo.

UB-311: Intramuscular injection

Placebo: Intramuscular injection

Subjects will receive 7 doses of placebo.

Placebo: Intramuscular injection

Overall Number of Participants Analyzed 14 15 14
Measure Type: Count of Participants
Unit of Measure: Participants
10
  71.4%
13
  86.7%
13
  92.9%
Time Frame 78 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 3 Priming Doses Followed by 4 Boosters 3 Priming Doses Followed by 2 Boosters Placebo
Hide Arm/Group Description

Subjects will receive 7 doses of UB-311.

UB-311: Intramuscular injection

Subjects will receive 5 doses of UB-311 and 2 doses of placebo.

UB-311: Intramuscular injection

Placebo: Intramuscular injection

Subjects will receive 7 doses of placebo.

Placebo: Intramuscular injection

All-Cause Mortality
3 Priming Doses Followed by 4 Boosters 3 Priming Doses Followed by 2 Boosters Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)      0/15 (0.00%)      0/14 (0.00%)    
Hide Serious Adverse Events
3 Priming Doses Followed by 4 Boosters 3 Priming Doses Followed by 2 Boosters Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/14 (7.14%)      3/15 (20.00%)      2/14 (14.29%)    
Eye disorders       
Retinal detachment   0/14 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0
Infections and infestations       
Pneumonia   0/14 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1
Herpes zoster   0/14 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Colon cancer   1/14 (7.14%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0
Lung adenocarcinoma   0/14 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1
Reproductive system and breast disorders       
Uterine prolapse   0/14 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
3 Priming Doses Followed by 4 Boosters 3 Priming Doses Followed by 2 Boosters Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/14 (28.57%)      6/15 (40.00%)      9/14 (64.29%)    
Gastrointestinal disorders       
Diarrhoea   0/14 (0.00%)  0 1/15 (6.67%)  1 4/14 (28.57%)  4
General disorders       
Injection site pain   0/14 (0.00%)  0 4/15 (26.67%)  4 3/14 (21.43%)  10
Fatigue   0/14 (0.00%)  0 2/15 (13.33%)  2 1/14 (7.14%)  2
Investigations       
Alanine aminotransferase increased   0/14 (0.00%)  0 1/15 (6.67%)  2 2/14 (14.29%)  3
Weight decreased   2/14 (14.29%)  2 1/15 (6.67%)  2 1/14 (7.14%)  1
Nervous system disorders       
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits   2/14 (14.29%)  5 2/15 (13.33%)  3 2/14 (14.29%)  4
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Site PIs must jointly publish results, unless permission is granted by Sponsor. If a joint publication is not done within 12 months after trial completion and database lock, then the site may publish its own results; provided that, a) Sponsor has 45 business days to review the proposed publication; b) the PI must delete any confidential information identified by Sponsor; and c) the PI must delay disclosure for 1 year if a patent application is filed by Sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Responsible Medical Officer
Organization: United Neuroscience
Phone: +(353) 1 524 0397
EMail: info@unitedneuroscience.com
Layout table for additonal information
Responsible Party: United Neuroscience Ltd.
ClinicalTrials.gov Identifier: NCT02551809    
Other Study ID Numbers: V203-AD
First Submitted: September 10, 2015
First Posted: September 16, 2015
Results First Submitted: December 24, 2019
Results First Posted: January 13, 2020
Last Update Posted: March 17, 2020