What are the main aims of the study?

Many people with Alzheimer’s experience changes in their sleep patterns. Scientists do not completely understand why this happens. While changes in memory and behaviour may be expected with Alzheimer’s, sleep changes are not always anticipated.

Sleep changes in Alzheimer’s may include the following:

• Difficulty sleeping. Many people with Alzheimer’s wake up more often and stay awake longer during the night.
• Daytime napping. Individuals may feel very drowsy during the day and then be unable to sleep at night.

The purpose of this clinical research study is to evaluate whether the investigational medication is effective and safe, compared with placebo, in improving insomnia in patients with insomnia and Alzheimer’s disease.

Dr Martin Allen, Principal Investigator for this study

What does it involve for a participant?

Before enrolling in the study, you will be asked to attend a screening visit where the study team will explain the study requirements and answer any questions you may have. The study team will ask you questions about your medical history and perform a physical examination and other tests. You must have a trial partner to accompany you at all trial visits. Following this initial visit to the clinic you will attend two more visits during the screening period and these will be overnight stays in a local sleep laboratory. The screening period may last up to three weeks.

If you qualify, you will be randomly assigned to receive either an inactive placebo or active investigational medication for up to four weeks. During this time you will visit your study doctor a further two times, then have another overnight sleep at the local sleep laboratory before seeing your doctor again at the end of the treatment period. Approximately 14 days later, your study doctor will contact you for a follow-up phone call.

How long is the study for?

Each patient will participate in the study for approximately nine weeks. There are 3 visits over a 3 week screening period (2 of them being overnight stays), followed by a further 3 visits over the 4 week treatment period (1 being a combination of an overnight stay and a clinic visit the following day). Finally a follow up telephone call will be received 2 weeks later.

What do you hope the outcomes of the study will be?

To study the effects on insomnia with this drug (which is licenced in USA and Japan as Belsomra ®) against placebo in patients specifically with Alzheimer’s Disease.

Where is the study based?

The study is recruiting throughout the UK based at sites in London, Guildford, Stoke and Middlesbrough.

Who can take part?

In order to be eligible for participation, you must:
• Be between the ages of 50 and 90 (inclusive)
• Have difficulty falling asleep and/or difficulty staying asleep. Have a diagnosis of insomnia and diagnosis of mild to moderate Alzheimer’s disease
• Have a reliable and competent trial partner (caregiver) who is willing to comply with administration and completion of study procedures and assessments

You will not be able to participate if you:
• Reside in a nursing home or similar institutional facility
• Have evidence of a certain clinically relevant neurological disorders other than Alzheimer’s

You can see if you are eligible for this study or others around the nation by logging into your Join Dementia Research account.

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