AlzCare™ for Alzheimer’s disease (Alz-Care-01)
Research type
Research Study
Full title
A phase 2, multi-centre, randomised, sham-controlled trial of the AlzCare™ medical device, to assess the safety, tolerability and clinical benefit of the AlzCare™ device in patients with Mild to Moderate Alzheimer’s disease.
IRAS ID
333582
Contact name
Neil Wright
Contact email
Sponsor organisation
Alzcare Ltd
Duration of Study in the UK
2 years, 2 months, 14 days
Research summary
This Alz-Care-01 study is to investigate whether the AlzCare™ device safe and well tolerated, and whether the AlzCare™ device shows any clinical benefit, for people with mild or moderate Alzheimer's disease (AD). There are currently no device treatments for AD available.
110 participants will enrol across 3-6 UK Non-NHS sites; men and women aged 60-85 years of age, who have mild or moderate Alzheimer's disease.
We will put eligible participants, at random, into two treatment groups, in a process called ‘randomisation’. Neither the participant nor the study doctor can choose or know the group that participants will be placed in; 1. An active AlzCare™ study device, delivering near-infrared light when in use or 2. A sham (or ‘placebo, or ‘dummy’) study device. Participants will receive a study device for use at home for up to 78 weeks.
AlzCare™ is a photobiomodulation device, delivering near-infrared light to stimulate the pre-frontal cortex region of the brain. Stimulation of this area can prevent the rate of neurodegeneration and treat the symptoms of AD.
Study participation is up to 88 weeks (approximately 20 months). Assessments include cognitive rating scales, a questionnaire, medical history, adverse events monitoring and brief physical examination.
Participants may not receive any benefit from the study; they may receive information about their health from assessments completed.
There may be risks. In studies of Low-Level Light Therapy (LLLT) side effects include minor headache, difficult sleeping and mild itching on the scalp. Participants may have a return, or worsening, of AD symptoms. Some may find questionnaires upsetting or embarrassing. Cognitive testing may cause upset, frustration, boredom or tiredness. Participants will complete two types of cognitive testing and one questionnaire during the trial, either with the support of an Assistant Psychologist or Doctor, as appropriate.
REC name
North of Scotland Research Ethics Committee 1
REC reference
24/NS/0018
Date of REC Opinion
1 Mar 2024
REC opinion
Favourable Opinion