None listed
Conditions
Brief summary
Open Label Extension Study to Evaluate the Safety, Tolerability and Cognitive Effects of VEL015 (Sodium Selenate) in Patients with Alzheimer’s Disease
Interventions
Sodium selenate (VEL015) 10mg oral capsules three time daily for 24 months
Sponsors
Velacor Therapeutics Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject must have been randomised, treated and completed Visit 6 and/or Visit 7 of Protocol Velacor 002 (ACTRN12611001200976). 2. 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. 3. 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) . 4. 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 5. 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 criteria
1. 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 . 2. 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). 3. Subject who is unlikely to comply with trial visit schedule or with trial medication. 4. Subject has a known sensitivity to selenium or sodium selenate or any medicine or vitamin containing sodium selenate or similar agents. 5. 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. 6. 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. 7. 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. 8. 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.
Outcome results
None listed