Submitted by: Nerissa C. Calimon 2015-02-03 00:00:00 Last Updated by: Nerissa C. Calimon 2015-02-04 10:44:15

Safety of Plasma Aβ1-42 and Aβ1-40 Reduction with H.E.A.L.E.R (Haemoadsorption for Extracorporeal Amyloid-β Level Expedited Reduction) using BETACLEAR BICARB 1000 in Healthy Elderly Individuals

Registry ID

PHRR150204-000946

Secondary Identification Number

Unspecified

FDA Clinical Trial Reference (CTR) Number

2012-CT0104

Scientific Title

Safety of Plasma Aβ1-42 and Aβ1-40 Reduction with H.E.A.L.E.R (Haemoadsorption for Extracorporeal Amyloid-β Level Expedited Reduction) using BETACLEAR BICARB 1000 in Healthy Elderly Individuals

Project Description

BETACLEAR BICARB 1000 will be used as the treatment modality in this study. It is a sodium bicarbonate compound with enhanced beta-amyloid extraction features that will be used as a component of dialysate in conjunction with a high-flux membrane dialyzer configuration for a haemodialysis procedure in bypass mode. The primary components in the procedure include BETACLEAR, a standard haemodialysis machine, a high-flux dialyzer and RO water. In standard hemodialysis, the blood runs through the dialysis machine, passing through a dialyzing chamber where any toxins in the patient’s blood pass through a semi-permeable membrane. The toxins then get washed away with a dialysate mixture on the other side of the membrane while the albumin remains with the blood. The active agent in BETACLEAR BICARB 1000, used in this process, specifically targets beta-amyloids and facilitates their extraction from the blood. The result is a reduction in the levels of toxic beta-amyloids (Aβ1-40 and Aβ1-42) in the patient’s body.

Project Duration

Start Date	Duration in Months	Target Completion Date	Actual Completion Date
2015-03-01	6	2015-09-01	0000-00-00

Project Status

Pending

Reason for project pending/suspension/termination

Not stated

Implementing Agency (Primary Sponsor)

Institution	Classification	Region	LTO #
Amylex Biotechnology Philippines, Inc.	Private Business	NCR

Cooperating Agency (Secondary Sponsor)

Institution	Classification	Region	LTO #
UST CeDRES	Private Business	NCR

Funding Agency (Sources of Monetary or Material Support)

Institution	Region
Amylex Biotechnology Philippines, Inc.	NCR

Contact for Public Queries

Name	E-Mail	Institution and Institution Address
Rachelle A. Llanes	rachellellanes@amylexlabs.com	1705 Prestige Tower Condominium, F. Ortigas Jr. Road, Ortigas Center, Pasig City

Contact for Scientific Queries

Name	E-Mail	Institution and Institution Address
Rachelle A. Llanes	rachellellanes@amylexlabs.com	1705 Prestige Tower Condominium, F. Ortigas Jr. Road, Ortigas Center, Pasig City

Investigating Team

Name	Expertise	Affiliation
Miguel A. Ramos, MD	Geriatrics	St. Luke's Medical Center - Quezon City

Project Location and Institutional Ethics Review Board

Project Location	Institutional Ethics Review Board
St. Luke's Medical Center - Quezon City	St. Luke's Medical Center Institutional Ethics Review Board

Health Condition(s) or Problem(s) Studied

Alzheimer's Disease

Primary Outcomes

Safety of H.E.A.L.E.R. procedure with the Amylex dialysate bicarbonate powder in normal elderly individuals

Key Secondary Outcomes

Comparative change from baseline in the plasma β-amyloid level with escalating duration and frequency of H.E.A.L.E.R. procedure in normal elderly individuals.
Comparative change from baseline in the CSF β-amyloid level after H.E.A.L.E.R. procedure in normal elderly individuals.

Recruitment Status

Pending

Countries of Recruitment

Philippines

Research Classification

Clinical Trial

FDA Document Tracking Number

Unspecified

FDA Approval Date

2014-03-11

ERC Approval Date

0000-00-00

Target Sample Size (Philippines)

Actual Sample Size (Philippines)

Unspecified

Reason for the difference between Target & Actual Sample Sizes

Unspecified

Date of First Enrollment

01 Mar 2015

Key Inclusion and Exlusion Criteria (CT)

Inclusion Criteria:
Subjects will be eligible for the study if they meet all of the following inclusion criteria.

1. Healthy male or female elderly determined with the use of clinical assessment, physical and cognitive assessment. They are individuals who are fully independent of activities of daily living.

2. Age Group: 50 to 70 years old

3. Signed and dated Informed Consent in accordance with GCP

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the following exclusion criteria

1. BMI: Outside of 19-25kg/m2 range

2. Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT) as determined during screening phase

3. History of renal impediment, defined by BUN and serum creatinine levels

4. History of Cardiovascular Event and/or Cardiac clearance failure

5. PT/aPTT/INR not within normal range

6. Failure in the Mini Mental State Examination (MMSE), Clock Drawing Test (CDT), Montreal Cognitive Assessment (MoCA), and either Geriatric Depression Scale (GDS) for subjects >60 years of age or Beck Depression Inventory (BDI) for subjects below 60 years old

7. Nursing or pregnant women

8. Women who are of child bearing potential and are not practicing an acceptable method of birth control. (Post-menopausal women are not subjected to undergo pregnancy test)

9. History of alcohol and drug abuse prior to informed consent

10. History of smoking, defined as more than 8 pack years with smoking cessation less than 2 years prior to screening.

11. Participation in another trial with an investigational device or product prior to signing informed consent

12. Planned surgery within 3 months

13. Intake of any Herbal Supplements (except Multivitamins)

14. Intake of any over the counter medication within the last 48 hrs.

15. Intake of any prescription medication for chronic conditions (i.e. antihypertensive, antidiabetic, etc)

16. Any distinctive medical history that will jeopardize the subject’s safety while participating in the clinical trial

Study Type

Interventional

Intervention Name

Betaclear Bicarb 1000

Intervention Description

from the blood. The result is a reduction in the levels of toxic beta-amyloids (Aβ1-40 and Aβ1-42) in the patient’s body.

Amendment Approval Date/Reasons

None

Method of Allocation

Randomized

Masking / Blinding

Not Applicable

Masking Details

Unspecified

Assignment

Single Arm

Purpose

To evaluate the safety of H.E.A.L.E.R. procedure with the Amylex dialysate bicarbonate powder in normal elderly individuals.

Phase

Phase I

Research Utilization

Utilization	Utilization Info
No records found.