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 University of Melbourne0 个研究点目标入组 60 人开始时间: 2020年4月23日最近更新: 2022年8月29日

适应症

试验速览

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•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.

•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.

发起方