Head Injury and Testosterone
- Conditions
- Traumatic Brain InjuryNeurological - Other neurological disordersInjuries and Accidents - Other injuries and accidents
- Registration Number
- ACTRN12613001219774
- Lead Sponsor
- The McCusker Alzheimer's Research Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 80
Male;
Aged 20 to 65 years old;
Brain injured with a severity of moderate to severe on admission Glasgow Coma Scale (GCS score of 7 to 12);
Able to personally read and understand the Participant Information and Consent Form, and provide written, signed and dated informed consent to participate in study;
Having been discharged from acute-care hospital stay and able to receive an initial injection within 3 months of injury;
Able and willing to meet all protocol-required procedures and visits.
Previous or ongoing chronic or recurrent disease of the central nervous system or psychiatric disease that may have an impact on cognitive performance (e.g. Bipolar disorder, Dementia, Schizophrenia, Parkinson’s disease etc.). This also includes drug/alcohol dependency related disorders;
People whose primary language is other than English;
Laboratory or clinical signs of untreated, clinically significant abnormal thyroid function;
Treatment with testosterone replacement therapy during the last five years;
Known history of prostate cancer, abnormal prostate evidenced by prostate examination, elevated levels of prostate specific antigen (PSA) (>4ng/mL) for participants age 50 years old and over;
Uncontrolled hypertension, diabetes mellitus, renal disease (eGFR <50 mL/min), cardiac disease, haematological disease, liver or lung disease;
Systolic Blood Pressure >170mmHg and Diastolic Blood Pressure >100mmHg
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To examine the cognitive and behavioural effects of the intervention compared to placebo, both objective tests and behavioural rating scales will be utilised. The primary outcome measures for this trial include the Mini Mental State Examination, Rey Auditory Verbal Learning Test, WAIS-III Digit Span, WAIS-III Digit Symbol Test, and Controlled Oral Word Association Test. The primary behavioural rating scale includes the Frontal Systems Behavior Scale, both patient and informant versions.[Approximately 12 months from initial treatment administration];To evaluate the blood and brain biomarkers associated with Alzheimer’s disease, and neuroinflammation in the intervention and placebo groups. This primary outcome assesses the change-from-baseline in biomarkers including the brain beta-amyloid burden, as measured by amyloid PET, plasma beta-amyloid, and inflammatory and oxidative markers.[Approximately 12 months from initial treatment administration]
- Secondary Outcome Measures
Name Time Method To examine the psychosocial outcomes of the intervention when compared to placebo, the Mayo-Portland Adaptability Inventory, both patient and informant versions will be used.[Approximately 12 months from initial treatment administration.];To examine participant quality of life after the intervention, the Epworth Sleepiness Scale and the Quality of life after Brain Injury will be used. [Approximately 12 months from initial treatment administration.]