Alzheimers disease Nervous System Diseases Alzheimer disease
Conditions
Interventions
Current interventions as of 04/06/2024:
The randomisation process will be conducted via sealed envelope design, using a double-blinded permuted block design with blocks of 3. Unique participant iden
Sponsors
AlzCare Ltd
Eligibility
Sex/Gender
All
Age
60 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Male and female participants aged 60 to 85 years of age inclusive, at the time of signing the informed consent 2. Has an MMSE score of 16 to 26 (inclusive) at the screening visit 3. Has an ADAS-Cog14 score of =15 at the screening visit 4. If a historic magnetic resonance imaging (MRI) is available, findings must exclude other causes of dementia 5. Has Mild to Moderate dementia due to AD, consistent with the NIA-AA Working Group Criteria [Albert et al. 2011; Jack et al. 2018; McKhann et al. 2011] 6. Women not of childbearing potential and males may participate in this study. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 7. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol 8. Can complete the cognitive testing and all other required study procedures 9. Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant, and will accompany the participant to study visits or be available by telephone at designated times 10. Are reliable and willing to make themselves available for the duration of the study 11. If treated with an AChEI, must be on a stable treatment for at least 12 weeks prior to the Baseline Visit and must be able to continue on the same drug for the duration of the study
Exclusion criteria
Exclusion criteria: 1. Have significant neurological disease affecting the central nervous system other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson’s disease, multiple concussions, or epilepsy or recurrent seizures, except febrile childhood seizures. 2. Have a condition requiring treatment, that in the investigator’s opinion could interfere with the analyses of this study, or a current serious or unstable illness, including: 2.1. Cardiovascular 2.2. Hepatic 2.3. Renal 2.4. Gastroenterologic 2.5. Respiratory 2.6. Endocrinologic 2.7. Neurologic other than AD 2.8. Psychiatric 2.9. Immunologic, or 2.10. Hematologic 3. Have a life expectancy of less than 24 months. 4. Any history of malignancy in the head or brain region. 5. Any radiotherapy in the head or brain region within 6 months prior to baseline or planned during the course of the trial. 6. Are in the investigator’s opinion, actively suicidal and deemed a significant risk for suicide. 7. Have a diagnosis of alcohol or drug use disorder, (except tobacco use disorder), within 2 years of the screening visit. 8. Have any medical condition (e.g. photophobia or abnormally high sensitivity to light) which makes the skin sensitive to sun or light or if they are allergic to this specific wavelength of light (800-820nm). 9. Have taken photosensitising medications or used photosensitising skincare products, within 12 weeks of baseline. 10. Are suffering from sunburn on the face or head at the time of the baseline visit. 11. Have a chronic skin condition on the head and/or face, which in the opinion of the investigator, could impact the use of the Alzcare™ device. 12. Have used low light therapy device(s) within 12 weeks of baseline, including sun beds, low light therapy beauty masks and devices for hair growth. 13. Are currently enrolled in any other interventional clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study. 14. Have ever received an Anti-amyloid or Anti-tau vaccine: Subjects who received active drug in a vaccine study are not eligible (subjects who received placebo are eligible). 15. Have participated in a clinical study and received active drug within 24 weeks of baseline (subjects who received placebo are eligible): 15.1. Anti-amyloid or anti-tau antibodies (passive immunotherapy) 15.2. ß-secretase or ß-site amyloid precursor protein cleaving enzyme (BACE) inhibitors 15.3. Amyloid anti-aggregation agents 15.4. Anti-complement, anti-inflammatory, kinase inhibitors or other mechanisms 16. Have previously completed or withdrawn from this study. This does not apply to participants who are allowed to rescreen before randomization in this study. 17. Are investigator site personnel directly affiliated with this study or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. 18. Are AlzCare Ltd employees or are employees of third-party organisations involved in the study that require exclusion of their employees or have study partners who are Alzcare Ltd employees or are employees of third-party organisations that require exclusion of their employees
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognition measured using the 14-item Alzheimer’s Disease Assessment Scale – cognitive subscale (ADAS-Cog 14) at screening, week 13, week 26, week 52 and week 78 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cognition measured using the Mini-Mental State Examination (MMSE) at screening and 78 weeks 2. The safety and tolerability of AlzCare™ measured using adverse event reporting over 78 weeks 3. The device compliance of AlzCare™ measured using downloaded device use data over 78 weeks | — |
Countries
England, United Kingdom
Contacts
Public ContactJames Jamieson-Black
Outcome results
None listed