Intervention of Testosterone & Fish Oil as a possible strategy for the Prevention of Alzheimer’s Disease

Exclusion Criteria30

• Pathological androgen deficiency (< 8 nmol/L)
• Baseline serum testosterone measurement >18 nmol/L within 6 months of study screening visit
• Use of any medication known to: affect testosterone or Sex Hormone Binding Globulin (SHBG) within the previous 1 month or with an underlying condition where there is any possibility that these may be required within the next 12 months
• Known to have hypothalamo-pituitary or testis pathology (excl. cryptorchidism)
• Screening ECG that shows evidence of a serious and/or unstable clinical significant condition as determined by the Investigator
• Laboratory or clinical signs of untreated, clinically significant abnormal thyroid function as deemed by the Investigator
• Clinically significant folic acid or vitamin B12 deficiency detected within 1 year prior to study consent
• Diagnosed with severe untreated Obstructive Sleep Apnoea or commenced Continuous positive airway pressure (CPAP) within the previous 6 months
• Type 1 diabetes mellitus
• Current clinically significant infection requiring systemic antibiotics
• Known to be human immunodeficiency virus (HIV) positive
• Participants should not be included in the study if they are taking chronic narcotic analgesic treatment (including codeine) anti-psychotics, tricyclic antidepressants, dopamine agonists, benzodiazepines, lithium, oral corticosteroids, other anti-cholinergics, cholinesterase inhibitors, paroxetine [an SSRI that is anticholinergic]
• Clinically significant non-malignant disease that is likely to lead to serious illness or death within 2 years, or in the opinion of the Clinical Investigator, requires other intervention
• Ongoing episode of major depression or other significant psychiatric or neurological disorders that may have an impact on cognitive performance such as schizophrenia, epilepsy, Parkinson’s disease or clinical episode of stroke.
• Breast, liver cancer or other malignancy within the last 5 years. Non-melanoma skin cancer (s) treated with curative intent are eligible if disease-free for at least 2 years
• Prior history of prostate cancer, above Upper Limit of Normal (ULN) for age-adjusted Prostate Specific Antigen (PSA) values or abnormal prostate on digital rectal examination (DRE)
• Personal or family history of thrombophilia, or taking anticoagulants, other than low dose Aspirin (100mg) for cardiovascular prophylaxis
• > 1.5 X Upper Limit of Normal coagulation profile
• Major cardiovascular event within the previous 6 months, or active cardiac disease
• Elevated blood pressure (above 160/100mmHg) at screening
• Haematocrit > 52% and Haemoglobin > 18.5 g/dL, or platelet counts <100,000 cells/uL
• ALT, GGT, Bilirubin or ALP > 3 times upper limit of normal (ULN)
• Known chronic viral hepatitis
• eGFR < 50 mL/minute
• Treatment with investigational medication within 2 months prior to informed consent
• Known history of drug or alcohol abuse within 6 months prior to the time of screening
• BMI > 35
• Lumbar spinal surgery within the last 6 months prior to screening, or any lumbar spinal surgery that interferes with anatomy of the inter-vertebral spaces
• History of chronic or repeat cerebrospinal fluid leakage following previous lumbar puncture
• Unable to have an MRI