Sensory Stimulation for Alzheimer's Disease

Recruiting at 52 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

402 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an open-label extension for a multicenter, randomized, double-blind, sham-controlled, adaptive design pivotal study. Participants who complete the Hope Study (CA-0011) will be eligible to consent for screening to enroll in the OLE Hope Study (CA-0015). 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 group or randomization involved in this study.

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 data supports the effectiveness of the Sensory Stimulation System (GS120) treatment for Alzheimer's Disease?

Research shows that sensory stimulation, like the 40Hz light and sound therapy, can improve memory and daily activity in people with Alzheimer's. Studies found that this type of therapy is safe and can help maintain brain function and improve cognitive test scores. ^{1 2 3 4 5}

Is sensory stimulation therapy safe for humans?

Small studies in humans using 40 Hz sensory therapy, which involves light and sound, have shown it to be safe and tolerable, with no reported side effects. ^{4 6 7 8 9}

How does the Sensory Stimulation System (GS120) treatment differ from other treatments for Alzheimer's disease?

The Sensory Stimulation System (GS120) is unique because it uses non-invasive sensory stimulation at a specific frequency (40 Hz) to potentially improve brain function in Alzheimer's patients. This approach, known as Gamma Entrainment Using Sensory stimulation (GENUS), aims to reduce Alzheimer's-related brain changes and improve cognitive performance, which is different from traditional drug treatments that primarily focus on symptom management. ^{1 2 3 4 10}

Research Team

Ralph Kern

Principal Investigator

Cognito Therapeutics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Gamma frequency sensory stimulation in mild probable Alzheimer's dementia patients: Results of feasibility and pilot studies. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Responses to stimuli in the 'snoezelen' room in unresponsive wakefulness or in minimally responsive state. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Sensory stimulation for persons with dementia: a review of the literature. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A Feasibility Study of AlzLife 40 Hz Sensory Therapy in Patients with MCI and Early AD. [2023]

5. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the effects of multi-sensory stimulation (MSS) for people with dementia. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Products for Alzheimer's self-stimulatory wanderers. [2017]

7. France pubmed.ncbi.nlm.nih.gov

Gamma-patterned sensory stimulation reverses synaptic plasticity deficits in rat models of early Alzheimer's disease. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of "isolated" transcutaneous electrical nerve stimulation on memory and affective behavior in patients with probable Alzheimer's disease. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Short-Term Effects of Rhythmic Sensory Stimulation in Alzheimer's Disease: An Exploratory Pilot Study. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

An update on the use of gamma (multi)sensory stimulation for Alzheimer's disease treatment. [2023]