A phase IIa clinical trial of VEL015 (sodium selenate) in mild to moderate Alzheimer's Disease

Phase 2

Recruiting

Conditions: Mild to Moderate Alzheimer's Disease
Neurological - Alzheimer's disease

Registration Number: ACTRN12611001200976

Lead Sponsor: Velacor Therapeutics

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Modified Hachinski Ischaemia Score of 4 or less
MMSE between 12-26
Acetylcholine esterase inhibitor (AChEI) treatment on a stable dose for at least 4mths
Living in the community with access to a carer

Exclusion Criteria

Treatment with memantine
Serious chronic uncontrolled disease other than Alzheimer's disease
Neurological illness that could contribute to non-Alzheimer's disease dementia
Epilepsy
Diabetes
Familial history of Alzheimer's Disease

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety & Tolerability- adverse events, vital signs, physical and <br>neurological examination, laboratory evaluations, ECG<br><br>Examples of possible adverse events:<br><br>Fatigue<br>Muscle spasms (cramping)<br>Alopecia<br>Nail disorders<br>Nausea<br>Diarrhoea<br>Decreased appetite<br>Lethargy<br>Dizziness<br>Vomiting[24 weeks after commencement of treatment and 4 weeks after last dose of treatment]

Secondary Outcome Measures

Name	Time	Method
Changes to Alzheimer's Disease biomarkers in the cerebrospinal fluid[24 weeks after commencing treatment];Effects on cognition as measured by Alzheimer's Disease Assessment Scale Cognitive Sub-scale, Mini Mental State Examination, Cogstate test and components of the Neuropsychological Test Battery[24 weeks after commencing treatment];Effect on atrophy of structures in the temporal lobe as determined by Magnetic Resonance Imaging and on the regional cerebral metabolic rate for glucose as determined by Fludeoxyglucose-Positron Emission Tomography[24 weeks after commencing treatment]

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A phase IIa clinical trial of VEL015 (sodium selenate) in mild to moderate Alzheimer's Disease

Recruitment & Eligibility

Study & Design

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