Sensory Stimulation for Alzheimer's Disease

Enrolling by invitation at 53 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cognito Therapeutics, Inc.

Must not be taking: Immunomodulators, Memantine, Nootropics

Disqualifiers: Insufficient adherence, Continuous care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for Alzheimer's Disease using a sensory stimulation device called GS120. The goal is to determine if daily use of this device over 12 months can improve symptoms. Participants must have completed a previous study called the Hope Study to join. The trial seeks individuals not living in continuous care facilities and who haven't recently started other specific Alzheimer's treatments. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in Alzheimer's treatment.

Will I have to stop taking my current medications?

You may need to stop taking certain medications to join this trial. Specifically, you cannot start or continue treatments like immunomodulators, memantine, or nootropic drugs, except for stable acetylcholinesterase inhibitors, during the study.

What prior data suggests that the Sensory Stimulation System (GS120) is safe for Alzheimer's patients?

Research has shown that the Sensory Stimulation System (GS120) is safe for people with Alzheimer's. In an earlier study, patients with mild to moderate Alzheimer's used this system and found it safe and easy to handle. No serious side effects were reported. This suggests that the treatment is well-tolerated, making it a promising option for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sensory Stimulation System (GS120) because it offers a non-drug approach to Alzheimer's disease, which is typically managed with medications like donepezil or memantine. Unlike these standard treatments, which work by altering brain chemicals, GS120 utilizes a sensory stimulation device designed for daily home use, providing a novel and potentially more accessible way to engage the brain. This method could offer a new avenue for managing symptoms by directly stimulating neural activity, which is a fresh perspective compared to traditional pharmaceutical approaches.

What evidence suggests that the Sensory Stimulation System (GS120) is effective for Alzheimer's Disease?

Research has shown that gamma sensory stimulation, which uses light and sound, can help slow the progression of Alzheimer's disease. Studies have found that this method can significantly reduce brain volume loss and thinning of the brain's outer layer. Additional research suggests it might also protect important brain structures needed for healthy function. In this trial, all participants will use the Sensory Stimulation System (GS120) daily, designed to provide these benefits and improve outcomes for people with Alzheimer's. ^{2 5 6 7 8}

Who Is on the Research Team?

Ralph Kern

Principal Investigator

Cognito Therapeutics

Are You a Good Fit for This Trial?

This trial is for individuals who have completed the Hope Study (CA-0011) and are dealing with various stages of Alzheimer's or cognitive impairment. They should be willing to use an Active Sensory Stimulation System daily.

Inclusion Criteria

Available/consenting Study Partner

Non-childbearing potential or using adequate birth control

I completed a year in the Hope Study (CA-0011).

Exclusion Criteria

I am starting or currently on Memantine treatment.

Insufficient adherence to treatment in the Hope Study (CA-0011)

I am starting or currently receiving immune therapy for Alzheimer's disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive the Active Sensory Stimulation System (GS120) for 60 minutes daily

12 months

1 clinic visit at 12 months, telephone visits at 6 and 13 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

1 telephone visit

What Are the Treatments Tested in This Trial?

Interventions

• Sensory Stimulation System (GS120)

Trial Overview Participants will use the Active Sensory Stimulation System (GS120) for one hour each day over a period of up to 12 months. This study aims to see if this treatment can help improve symptoms related to Alzheimer's and cognitive decline.

How Is the Trial Designed?

Group I: Active Experimental Treatment 1 Intervention

All subjects will receive a device with Active settings for use daily at home for 60-minutes for 12 months.

Who Is Running the Clinical Trial?

Cognito Therapeutics, Inc.

Lead Sponsor

Trials

4

Recruited

1,100+

Published Research Related to This Trial

In a study involving 18 Alzheimer's disease patients across different stages, 40 Hz sound stimulation showed significant improvements in cognitive function compared to visual stimulation, particularly in those with mild and moderate AD.

The results suggest that 40 Hz sound treatment could be a promising new approach for enhancing cognitive function in Alzheimer's patients, warranting further research to explore its efficacy and mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-Term Effects of Rhythmic Sensory Stimulation in Alzheimer's Disease: An Exploratory Pilot Study. Clements-Cortes, A., Ahonen, H., Evans, M., et al.[2018]

Gamma Entrainment Using Sensory stimulation (GENUS) shows promise as a non-pharmacological treatment for Alzheimer's disease, with animal studies indicating it can positively affect cognitive decline and reduce amyloid plaques and neurofibrillary tangles.

Although research on GENUS in humans is still in early stages, initial findings suggest it is feasible and warrants further investigation to establish its effectiveness as a disease-modifying intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update on the use of gamma (multi)sensory stimulation for Alzheimer's disease treatment. Manippa, V., Palmisano, A., Filardi, M., et al.[2023]

Multi-Sensory Stimulation (MSS) significantly improved immediate behavior and mood in older adults with dementia, leading to increased spontaneous talking, better social interaction, and greater alertness compared to a control group engaged in one-to-one activities.

While both MSS and Activity sessions were effective during the trial, only MSS showed lasting improvements in mood and behavior at home, although no long-term benefits were observed after a month, indicating a need for ongoing intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the effects of multi-sensory stimulation (MSS) for people with dementia. Baker, R., Bell, S., Baker, E., et al.[2022]

Daily exposure to 40 Hz synchronized sound and light stimuli for 2 weeks significantly improved hippocampal long-term potentiation (LTP) in three rat models of early Alzheimer's disease, suggesting a potential therapeutic effect.

The improvement in LTP was linked to a reduction in pro-inflammatory mechanisms, as indicated by a negative correlation with active caspase-1 levels, highlighting the importance of inflammation in the treatment strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gamma-patterned sensory stimulation reverses synaptic plasticity deficits in rat models of early Alzheimer's disease. Yang, Y., Ondrejcak, T., Hu, NW., et al.[2023]

The GENUS device, which uses 40Hz sensory stimulation, was found to be safe and effective in inducing brain entrainment in both cognitively normal individuals and patients with mild Alzheimer's disease (AD) during a Phase 1 feasibility study involving 43 participants.

In a Phase 2A pilot study with 15 patients, chronic daily 40Hz stimulation led to significant improvements in brain health, including reduced hippocampal atrophy and better cognitive performance, suggesting its potential as a novel treatment for AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gamma frequency sensory stimulation in mild probable Alzheimer's dementia patients: Results of feasibility and pilot studies. Chan, D., Suk, HJ., Jackson, BL., et al.[2023]

A systematic review of 55 studies on sensory stimulation interventions for individuals with dementia found that 30 of these studies reported significant effects, primarily in reducing negative behaviors, although many studies had methodological limitations.

The review categorized various sensory interventions, such as music therapy and aromatherapy, and highlighted the need for further research to better understand their impact on quality of life and communication, especially considering different stages of dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory stimulation for persons with dementia: a review of the literature. Strøm, BS., Ytrehus, S., Grov, EK.[2022]

A non-invasive 40 Hz sensory therapy using light and sound was found to be safe and tolerable in a small group of 27 participants with Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD), with 11 completing 6 months of therapy.

Some participants showed cognitive improvements, with 2 out of 4 with subjective complaints and 2 out of 6 with AD improving their Montreal Cognitive Assessment (MOCA) scores, suggesting potential benefits of this therapy that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Feasibility Study of AlzLife 40 Hz Sensory Therapy in Patients with MCI and Early AD. McNett, SD., Vyshedskiy, A., Savchenko, A., et al.[2023]

Snoezelen stimulation significantly improved communication scores in patients with minimally conscious state (MCS), indicating its potential efficacy in enhancing responsiveness after brain injury, with scores increasing from 28.48 to 31.13 (p < 0.001).

Physiological changes were observed during stimulation, including increased heart rate and decreased cerebral blood flow velocity in the left hemisphere for MCS patients, suggesting that Snoezelen may influence arousal and brain function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responses to stimuli in the 'snoezelen' room in unresponsive wakefulness or in minimally responsive state. Lehrer, H., Dayan, I., Elkayam, K., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05637801?cond=Alzheimer%20Disease&term=cognito%20therapeutics&intr=sensory%20stimulation&rank=2

A Pivotal Study of Sensory Stimulation in Alzheimer's ... The objective of the study will be to assess efficacy of gamma sensory stimulation (visual and audio) in slowing disease progression versus Sham for subjects ...

2. withpower.com withpower.com/trial/phase-dementia-of-the-alzheimers-type-1-2024-1a88a

Sensory Stimulation for Alzheimer's Disease All participants will be treated with an Active Sensory Stimulation System (GS120) for 60 minutes daily for up to 12 months. There will be no Sham treatment ...

3. trialstoday.org trialstoday.org/trial/NCT05637801

A Pivotal Study of Sensory Stimulation in Alzheimer's ... Up to approximately 670 subjects will be randomized to 12 months of daily treatment with either Active or Sham Sensory Stimulation Systems.

4. medrxiv.org medrxiv.org/content/10.1101/2023.03.23.23287637v1.full.pdf

Safety, Tolerability and Efficacy of 40Hz Sensory ... Additionally, sensory stimulation also showed a significant reduction in brain volume loss and cortical thinning, without changes in amyloid PET ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10957179/

Safety, tolerability, and efficacy estimate of evoked gamma ... Noninvasive gamma sensory stimulation may reduce white matter and myelin loss in Alzheimer's disease. J Alzheimers Dis. (2024) 97:359–72 ...

6. withpower.com withpower.com/trial/phase-early-onset-alzheimers-disease-ad-11-2022-2a2e1

Sensory Stimulation for Alzheimer's Disease (Hope Trial) The feasibility study of AlzLife 40 Hz Sensory Therapy in patients with MCI and early AD reported that the therapy was safe and tolerable, with no reported side ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05637801

NCT05637801 | A Pivotal Study of Sensory Stimulation in ... This is a randomized, double-blind, sham-controlled, adaptive-design pivotal study of sensory stimulation in subjects with mild to moderate Alzheimer's ...

8. ctv.veeva.com ctv.veeva.com/study/a-pivotal-study-of-sensory-stimulation-in-alzheimers-disease-hope-study-ca0011

A Pivotal Study of Sensory Stimulation in Alzheimer's Disease ... In the Control Group, subjects are treated with a Sham Sensory Stimulation System once daily. Daily treatment is planned for up to 12 months.