A study investigating whether testosterone and omega 3 from fish oil has an effect on the accumulation of protein plaques linked to Alzheimer’s disease in older men concerned about their memories

Phase 2

Recruiting

• Conditions: Dementia; Subjective Memory Complaints; Age-related cognitive decline; Cognitive Impairment; Neurological - Dementias

• Registration Number: ACTRN12618000761268
• Lead Sponsor: Australian Alzheimer's Research Foundation Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-07
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

1. Men aged 60 – 80 years at the time of signing the consent
2. Able to personally read and understand the Participant Information and Consent Form and provide written, signed and dated informed consent to participate in the study
3. Able and willing to meet all protocol-required procedures and visits
4. Must have an available project partner who has sufficient contact (at least 5 hours per week) with the participant to provide reliable information on the cognitive and functional abilities of the participant
5. Must have Global PiB-like SUVR score of 1.3 - 2.0 on PET (completed within 12 months of Day 1)
6. A MoCA score of 23 to 30 at the Screening Visit dependant on age and education, see appendix III
7. A score of greater than or equal to 25 on Memory Complaints Questionnaire (MAC-Q) at Screening Visit
8. General cognition and functional performance are preserved to the extent that that no suspected or possible Mild Cognitive Impairment or AD with dementia exists based on the results of neuropsychological testing at Screening IV. Note: If a comparable neuropsychological battery (as determined by the lead neuropsychologist) has been performed
within 4 months of screening, the data collected can be used to assess this criterion.
9. Visual and auditory acuity to perform the cognitive tests (eyeglasses and hearing aids permitted)
10. Be willing to provide a blood sample for Apolipoprotein E (APOE) genotyping

Exclusion Criteria

1. Pathological androgen deficiency (< 8 nmol/L) in accordance with current Pharmaceutical Benefits Scheme guidelines requiring testosterone replacement, or testosterone supplementation during the previous 2 years
2. Serum testosterone measurement greater than or equal to 18 nmol/L within 6 months of study or at the Screening Visit
3. Use of any medication known to:
• Affect testosterone or SHBG within the previous 1 month or with an underlying condition where there is any possibility that permanent usage may be required within the next 12 months
• Affect the production (e.g. opiates, GnRH agonists) or action (e.g. spironolactone) of androgens
• Affect the production [e.g. opiates, GnRH agonists] or action [e.g. spironolactone, Duodart (combination of Tamsulosin and Dutasteride), Avodart (Dutasteride)] of androgens
4. Known to have hypothalamo-pituitary or significant testis pathology (excl. cryptorchidism)
5. Known clinically significant folic acid or B12 deficiency
6. Diagnosed with severe untreated Obstructive Sleep Apnoea (OSA) or commenced CPAP within the previous 6 months
7. Type 1 diabetes mellitus
8. Clinically significant systemic illness or serious infection (e.g., pneumonia, septicemia) within 30 days prior to or during Screening
9. Known to be Human Immunodeficiency Virus (HIV) positive
10. 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] – If any of these drugs are taken intermittently (no more than three times a week) there should be no use within 2 days of any cognitive testing *In the case of low dose corticosteroids, if in the opinion of the investigator the dose of the drug is sufficiently low to not represent a significant anti-cholinergic burden, then the subject can be included in the study
11. Ongoing episode of major depression, or current diagnosis or history of schizophrenia, bipolar disorder or any other psychiatric condition which could significantly interfere with their cooperation in participating in the study
12. Significant neurological or medical disorders that in the opinion of the investigator may impair cognitive performance such as epilepsy, Parkinson’s disease, clinical episode of stroke/TIA. In these instances, consensus agreement with the sponsor regarding participant eligibility should be sought
13. History of malignancy of any organ treated within the past 2 years, regardless of whether there is evidence of local recurrence or metastases. However localised basal cell carcinoma or localised squamous cell of the skin are permitted
14. Prior history of prostate cancer or:
• > ULN for age-adjusted PSA values
• Clinical suspicion of malignancy on digital rectal examination (DRE) o Except where the participants have been assessed by an urologist and all causes for high PSA/abnormal size on DRE other than Benign Prostatic Hyperplasia /Prostatitis have been ruled out
• High risk of prostate cancer according to family history (men with one or more first-degree relatives diagnosed <65yo, or men with a first-degree relative with familial breast cancer (BRCA1 or BRCA2))
15. Personal or family history of thrombophilia, or personal history of deep vein thrombosis (DVT) / pulmonary embolism

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in brain amyloid levels as measured by 18F-Flutemetamol positron emission tomography (PET) scans [Baseline and then every 8 weeks until the end of treatment (56 weeks).]