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

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2013
INTERVENTION: testosterone undecanoate 1000mg/ 4ml (intramuscular injection) every 8 weeks, for 56 weeks Docosahexaenoic acid (DHA) capsules, 4 capsules per day (total daily dose of 1720mg of DHA) for 56 weeks There are 3 treatment arms: Arm 1: Testosterone 1000mg/4 ml plus 1720 mg of DHA Arm 2: Testosterone 1000mg/4 ml plus placebo‐DHA Arm 3: placebo‐testosterone plus placebo‐DHA CONDITION: In men with Subjective Memory Complaints PRIMARY OUTCOME: The primary outcome of the study will be a decrease in Pittsburgh compound B (PiB) score at 13 months of at least 4% from the baseline score. SECONDARY OUTCOME: A comprehensive battery of questionnaires & structured interviews will be used to access the neuropsychological, mood, and daily functioning measures to assess the efficacy of treatment interventions in comparison to placebo on cognitive functions. ; Questionnaires will include: Mini Mental State Examination, Memory for Intentions Screening Test, Benton Visual Retention Test, Stroop Neuropsychological Screening Test, Memory Complaints Questionnaire and Prospective and Retrospective Memory Questionnaire, World Health Organization Quality of Life measure, Activities of Daily Living Questionnaire Brain Magnetic Resonance Imaging (MRI) will be used to measure change in hippocampal volume to evaluate treatment intervention in the different groups. Evaluate the treatment intervention on inflammatory & oxidative exploratory biomarkers. Fluorodeoxyglucose (FDG) PET scans will evaluate the efficacy of treatment interventions at improving brain glucose metabolism compared to the placebo control group. The safety and tolerability of the treatment interventions compared to placebo will be assessed. The treatment impact on Quality of Life (QoL) using the following Q of L questionnaires (WHO Qol & SF‐36) will be assessed. To evaluate the treatment interventions on plasma and/or cerebrospinal fluid (CSF) beta amyloid levels compared to placebo. INCLUSION CRITERIA: 1. Men aged 60 years or over 2. Able to personally read and understand the Participant Information and Consent Form and provide written, signed and dated informed consent to participate in study 3. Able and willing to meet all protocol‐required procedures and visits 4. Must have an available informant who is knowledgeable about the participant, who has a minimum of 5 hours contact per week and can provide a reliable way to determine cognitive status of the participant 5. Participants must be PiB‐PET positive based on cut‐off level of greater than 1.5 SUVR and PET scan done within 6 months at time of commencement of treatment if deemed eligible to participate 6. Mini Mental State Examination (MMSE) greater than 24 as stratified by age and education (i.e. cognitively normal), with inclusion at the discretion of the investigator team (after taking into consideration, age, education, medical, neurological and psychiatric condition) 7. A score of
Epistemonikos ID: 19d63f8b416aa6ea8367669575a138251c2f8a96
First added on: Aug 22, 2024