A Phase II randomised, double-blind, placebo-controlled trial of S-Adenosyl Methionine (SAMe) in participants with mild cognitive impairment or dementia due to Alzheimer’s disease

Phase 2

Recruiting

• Conditions: Alzheimer's disease; Neurological - Alzheimer's disease; Mild Cognitive Impairment; Mental Health - Other mental health disorders

• Registration Number: ACTRN12620000506998
• Lead Sponsor: The University of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-23
• Last Update Posted: 29 August 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma levels of p-tau181[Screening and six months (primary endpoint). ]

Secondary Outcome Measures

Name	Time	Method
Cognitive function assessment by RBANS,[Screening and six months (secondary endpoint).];Epigenetic changes in DNA methylation. [Screening and six months (secondary endpoint). ];Safety assessment via the presence or absence of AE's and SAE's, assessed via participant or study partner self-report, physical examination, vital sign measurement and clinical safety blood testing at all visits. <br><br>Known/possible adverse events of SAMe drug may include agitation, anxiety, irritation, and restlessness and the potential to trigger bipolar episodes. There is also a theoretical risk of serotonin syndrome if combined with anti-depressant medications. As such, the study specifically excludes enrolment of individuals with a history of bipolar affective disorder, recent unstable psychiatric condition, or concurrent antidepressant intake.[Screening, Randomisation, 1 month, 3 months, six months, follow up (2 weeks post-treatment).]