RecruitingPhase 2ACTRN12613000170729
Open Label Extension Study to Evaluate the Safety, Tolerability and Cognitive Effects of VEL015 (Sodium Selenate) in Patients with Alzheimer’s Disease
Sponsor
Velacor Therapeutics Pty Ltd
Enrollment
40 participants
Start Date
Oct 30, 2012
Study Type
Interventional
Conditions
Summary
Open Label Extension Study to Evaluate the Safety, Tolerability and Cognitive Effects of VEL015 (Sodium Selenate) in Patients with Alzheimer’s Disease
Eligibility
Sex: Both males and femalesMin Age: 55 Yearss
Inclusion Criteria19
- Subject must have been randomised, treated and completed Visit 6 and/or Visit 7
- of Protocol Velacor 002 (ACTRN12611001200976).
- The Baseline (Month 0) visit must be conducted no more than 2 months after the
- last scheduled visit (Visit 6 or Visit 7) for Protocol Velacor 002.
- Females must be of non-child-bearing potential. Male subjects with female
- partners of child-bearing potential should use effective contraception for the
- duration of the Study and continue it for 12 weeks after cessation of IMP
- administration. Women of non-childbearing potential must be either surgically
- sterile (hysterectomy and/or oophorectomy) or postmenopausal at least 1 year and
- must have a negative urine pregnancy test result at or within 28 days prior to the
- Baseline Visit (Visit 1) .
- Subject must be living in the community and have at least 5 contact hours per
- week with a responsible carer. The carer should be capable of ensuring the
- subject's compliance with the medication, be prepared to attend with the subject
- for assessment and be willing to participate in completing the various assessments
- throughout the period of the subject’s involvement in the Study
- Written informed consent must be obtained from the subject or legally authorised
- representative (as required by local laws and regulations), and the participant’s
- carer.
Exclusion Criteria28
- Subject who has experienced persistent or unresolved side effects thought to be
- possibly/probably/very likely/certainly related to Study Drug in the Velacor 002 study
- and where the event is classified as either greater than or equal to Grade 3 severity or as a Serious
- Adverse Event, or where the event required permanent cessation of Study Drug .
- Subject has participated in a clinical investigation of a medication (with exception of
- Velacor 002 study) or device within the 3 months prior to the Baseline Visit (Visit 1).
- Subject who is unlikely to comply with trial visit schedule or with trial medication.
- Subject has a known sensitivity to selenium or sodium selenate or any medicine or
- vitamin containing sodium selenate or similar agents.
- Subject has a primary, secondary or pseudodementia other than probable
- Alzheimer's Disease, or has current evidence or history of neurological, psychiatric
- and any other illness that could contribute to non-Alzheimer's dementia.
- Subject has a significant medical disease, with the exception of Alzheimer’s Disease
- that:
- is not adequately controlled by therapy; and/or
- in the opinion of the investigator may interfere with the patient’s ability to complete
- the study or might impact on the patient’s cognitive performance.
- Subject has significant impairment of any of the following for the age of the subject,
- which may compromise safety of the subject/validity of the data:
- Renal function (i.e. estimated glomerular filtration rate (eGFR) < 30)
- Hepatic function (i.e. abnormal liver function tests greater than or equal to 2 x upper limit of normal)
- Haematological function.
- Subject is currently taking any of the following:
- Dietary supplement containing > 26 micrograms selenium
- Carbamazepine, digoxin, phenobarbitone, phenytoin, warfarin or any other
- medication that has a narrow margin between effective dose and toxic dose or
- between effective dose and ineffective dose, where the subject would be at risk if
- the levels were elevated or fell due to interaction with VEL015.
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Interventions
Sodium selenate (VEL015) 10mg oral capsules three time daily for 24 months
Sodium selenate (VEL015) 10mg oral capsules three time daily for 24 months
Locations(3)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12613000170729