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

PHRR150204-000946

Unspecified

2012-CT0104

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

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.

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

Pending

Not stated

Institution Classification Region LTO #
Amylex Biotechnology Philippines, Inc. Private Business NCR
Institution Classification Region LTO #
UST CeDRES Private Business NCR
Institution Region
Amylex Biotechnology Philippines, Inc. NCR
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
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
Name Expertise Affiliation
Miguel A. Ramos, MD Geriatrics St. Luke's Medical Center - Quezon City
Project Location Institutional Ethics Review Board
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Board

Alzheimer's Disease

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

  1. 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.
  2. Comparative change from baseline in the CSF β-amyloid level after H.E.A.L.E.R. procedure in normal elderly individuals.

Pending

  • Philippines

Clinical Trial

Unspecified

Unspecified

2014-03-11

0000-00-00

3

Unspecified

Unspecified

01 Mar 2015

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

Interventional

Betaclear Bicarb 1000

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.

None

Randomized

Not Applicable

Unspecified

Single Arm

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

Phase I

Utilization Utilization Info
No records found.

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