None listed
Conditions
Brief summary
Despite advances in the understanding of the underlying mechanisms of Alzheimer’s disease (AD) the commonest form of dementia, no effective disease modifying therapy exists to date. Plaques containing Amyloid-ß (Aß) and neurofibrillary tangles consisting of hyperphosphorylated tau are the core pathological hallmarks of AD. Widespread predominantly non-prescription use of S-adenosyl methionine (SAMe) currently occurs mainly for depression, osteoarthritis and liver disease. Given its critical role in tau homeostasis, a unique opportunity exists to examine the efficacy and safety of SAMe in a clinical trial of patients with Alzheimer’s disease. It is hypothesised that after six months of treatment with 400mg of oral SAMe, participants with mild cognitive impairment or mild AD will show reduced levels of p-tau181 in their plasma.
Interventions
400mg S-adenosyl methionine, oral capsules, once daily for 6 months. Drug accountability will be monitored to ensure compliance at every visit.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female participants aged 60 years and above at the time of signing the informed consent. 2. Participants who have mild cognitive impairment or dementia due to Alzheimer’s disease, according to the NIA-AA 2011 criteria. 3. Participants who have a standardised mini-mental state examination (sMMSE) score of 18 or above. 4. If using medications to treat symptoms of AD (e.g. donepezil), doses must be stable for at least 8 weeks prior to screening. 5. Living at home or in a community setting (assisted living) without continuous nursing care. Each subject must have a reliable caregiver or study partner who sees them at least 3 times weekly, can oversee the administration of study drug, and is willing and able to participate in all clinic visits and some study procedures. The responsible caregiver/ study partner must provide written informed consent to participate.
Exclusion criteria
1. Any history of bipolar affective disorder. 2. Any medical condition (other than AD) which may contribute to the participant’s cognitive impairment. 3. Stroke or transient ischaemic attack in the past 1 year. 4. Clinically significant unstable psychiatric condition in the last 6 months. 5. Inability to swallow oral medications. 6. Other medical conditions, which in the opinion of the investigator, would limit the participant’s survival to < 6 months. 7. Concurrent use of anti-depressant medication (due to the possibility of serotonin syndrome). 8. Participation in another interventional clinical trial or intake of investigational drug within 4 weeks or 5 half-lives (whichever is longer) of the screening visit.
Outcome results
None listed