The SAMe Study: 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

The SAMe Study is a research project investigating a potential treatment for Alzheimer's disease, called S-Adenosyl Methionine, or more commonly known as “SAMe”. It is thought that Alzheimer's disease may be caused by the toxic build-up of proteins in the brain such as tau and amyloid-beta. This study is looking at whether taking SAMe once a day will reduce tau protein levels.

You or the person you care for are invited to take part because you or they have been diagnosed with mild cognitive impairment or dementia due to Alzheimer’s disease.

To be eligible for the study, you or the person you care for must:

• Be aged 60 years or above
• Be diagnosed with mild cognitive impairment (MCI) or dementia due to Alzheimer’s disease
• Have a close family member, friend or caregiver who can provide support and attend visits
• Be able to complete cognitive testing in English
• Have no diagnosis of bipolar affective disorder    
• Have not had a stroke or transient ischaemic attack in the past 1 year
• Not be using anti-depressant medication at present

There is research evidence to suggest that SAMe may reduce the levels of toxic tau in the brain. We will measure levels of tau in the blood at the beginning and end of the study to see if taking SAMe once a day helps to reduce tau levels.

Participants in the study will be asked to take 1 tablet a day for 6 months of SAMe or placebo. There will be 5 study visits plus 1 telephone call over a 6-month period. Some of these visits may be conducted in the participant’s home. Participants will be assessed by a doctor who will perform a physical examination and take their medical history. Blood tests will be performed at 4 visits, and 2 visits will have memory and thinking tests.