| Trial name or title | Intervention of testosterone and fish oil for the prevention of Alzheimer's Disease: InTrePad |
| Methods | RCT |
| Participants | PiB‐PET (Pittsburgh compound B) positive men aged 60 years and over with subjective memory complaints |
| Interventions | Each for 56 weeks: Arm 1: DHA capsules (1720 mg/d) and testosterone undecanoate (intramuscular injection 1000 mg/4 mL every 8 weeks) Arm 2: placebo DHA and testosterone undecanoate (intramuscular injection 1000 mg/4 mL every 8 weeks) Arm 3: placebo DHA and placebo testosterone |
| Outcomes | Primary: PiB score Secondary: neuropsychological, mood and daily functioning questionnaires, beta amyloid levels, fluorodeoxyglucose to assess brain glucose metabolism, inflammatory and oxidative biomarkers, hippocampal volume, quality of life, safety and tolerability of treatment |
| Starting date | Registered on trials registry: 14 January 2013 Study start date: 28 February 2013 Estimated study completion date: not stated |
| Contact information | Ralph Martins (PI), Sir James McCusker Alzheimer's Disease Research Unit, Hollywood Medical Centre, Nedlands, Australia, r.martins@ecu.edu.au |
| Notes | ACTRN12613000034730 Ralph Martins written to in 2016‐ no response |
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