Open Label Extension Study to Evaluate the Safety, Tolerabilityand Cognitive Effects of VEL015 (Sodium Selenate) in Patientswith Alzheimer’s Disease
- Conditions
- Mild to moderate Alzheimer's diseaseNeurological - Alzheimer's disease
- Registration Number
- ACTRN12613000170729
- Lead Sponsor
- Velacor Therapeutics Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method