Sensory Stimulation for Alzheimer's Disease

(Hope Trial)

Recruiting at 61 trial locations

Overseen By Alex Konisky

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Academic

Sponsor: Cognito Therapeutics, Inc.

Must be taking: Acetylcholinesterase inhibitors

Must not be taking: Nootropics, Memantine, BACE inhibitors, others

Disqualifiers: Seizure disorder, Schizophrenia, Heart disease, others

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

Compensation: Varies

Number of Visits: 8

Duration: 12 months

600 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a device that uses light and sound to help patients with mild to moderate Alzheimer's disease. The goal is to see if this sensory stimulation can slow down the progression of the disease by improving brain function. This therapy has shown potential for application in the treatment of Alzheimer's disease.

Do I need to stop taking my current medications for this trial?

The trial does not specify if you need to stop all current medications, but you cannot take nootropic drugs except stable acetylcholinesterase inhibitors, and you must not have been on Memantine (Namenda or Namzaric) in the last 30 days. It's best to discuss your specific medications with the trial coordinators.

What data supports the idea that Sensory Stimulation for Alzheimer's Disease is an effective treatment?

The available research shows that sensory stimulation can have positive short-term effects on people with dementia, including those with Alzheimer's Disease. For example, one study found that sensory stimulation in a special room increased responsiveness in patients with brain injuries and dementia. Another study observed that patients in the final stage of Alzheimer's reacted to music, touch, and objects, suggesting some level of engagement. However, the research also indicates that these effects are mostly short-term, and there is limited evidence of long-term benefits. Compared to other treatments, sensory stimulation may offer immediate improvements in behavior and mood, but its lasting impact is still uncertain. ^{1 2 3 4 5}

What safety data exists for sensory stimulation treatment in Alzheimer's?

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 effects. However, some participants faced challenges with compliance and using the smart tablet required for the therapy. Further exploration of the treatment's efficacy is warranted. ^{1 2 5 6 7}

Is the Sensory Stimulation System (GS120) a promising treatment for Alzheimer's Disease?

Yes, the Sensory Stimulation System (GS120) is a promising treatment for Alzheimer's Disease. Studies show that it can improve sleep and daily activities in patients by using light and sound to help the brain work better. It has been safe and well-tolerated in trials, with many patients maintaining or improving their abilities over time. ^{1 3 4 6 8}

Research Team

Ralph Kern, MD

Principal Investigator

Cognito Therapeutics

Eligibility Criteria

This trial is for individuals aged 50-85 with mild to moderate Alzheimer's disease who can attend study visits with someone knowledgeable about their symptoms. They must have stable chronic conditions, adequate vision and hearing, at least 8 years of education, and not be in childbearing potential or agree to use birth control.

Inclusion Criteria

I have been diagnosed with Alzheimer's disease.

I have someone who can come with me to clinic visits and talk about my symptoms.

Exclusion Criteria

Your MMSE score is between 15 and 26.

I can name someone legally allowed to make decisions for me.

I can see light and hear sounds.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive daily sensory stimulation treatment with either Active or Sham Sensory Stimulation Systems for up to 12 months

12 months

Visits at Baseline, 3-Months, 6-Months, 9-Months (by phone), 12-Months

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

1 visit (in-person) at 13 Months

Substudy

Select participants undergo lumbar puncture to collect cerebrospinal fluid (CSF) at Baseline, 3 Months, and 12 Months

12 months

3 visits (in-person) for CSF collection

Treatment Details

Interventions

• Sensory Stimulation System (GS120) - Active
• Sensory Stimulation System (GS120) - Sham

Trial Overview The Hope Study tests a Sensory Stimulation System (GS120) on people with Alzheimer's. Participants are randomly assigned to receive either the active system or a sham (fake) version daily for 12 months. Their abilities will be assessed using specific activities of daily living and mental state exams.

Participant Groups

Group I: Active Experimental Treatment 1 Intervention

Treatment Group: Subjects are treated with the Active Sensory Stimulation System at home for 60 minutes daily for up to12 months.

Group II: Control Placebo Group 1 Intervention

Control Group: Subjects are treated with a Sham Sensory Stimulation System at home for 60 minutes daily for up to 12 months.

Sensory Stimulation System (GS120) - Active is already approved in United States for the following indications:

Approved in United States as GS120 for:

• Mild to Moderate Alzheimer's Disease

Who Is Running the Clinical Trial?

Cognito Therapeutics, Inc.

Lead Sponsor

Trials

4

Recruited

1,100+

Findings from Research

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]

Multisensory stimulation (MSS) programs, designed to support patients with reduced perception and cognition, show some positive short-term effects on behavior in individuals with conditions like coma, dementia, or learning disabilities, but evidence of long-term effectiveness is lacking.

A critical review of existing studies reveals a significant shortage of research on MSS, indicating that while short-term benefits may justify its use, more rigorous studies are needed to establish its overall efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of multisensory stimulation interventions in brain-damaged patients]. Heidler, MD.[2008]

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]

In a study involving two patients in the final stage of Alzheimer's dementia, music stimulation was found to elicit different responses compared to touch and object presentation, highlighting the varied effects of sensory stimuli on individuals with dementia.

The study utilized direct observations, video recordings, and physiological measurements (pulse and respiration) over 12 days, suggesting that personalized sensory interventions may be beneficial in engaging patients with advanced dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reactions to music, touch and object presentation in the final stage of dementia. An exploratory study. Norberg, A., Melin, E., Asplund, K.[2019]

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]

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]

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]

A 6-month study involving 22 patients with mild to moderate Alzheimer's disease showed that daily 40 Hz gamma sensory stimulation therapy was well tolerated and helped maintain functional abilities, unlike the sham group which experienced a decline.

Patients receiving the active treatment had improved sleep quality, as indicated by reduced nighttime activity, suggesting that gamma sensory stimulation may have beneficial effects on both sleep and cognitive function in Alzheimer's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory-Evoked 40-Hz Gamma Oscillation Improves Sleep and Daily Living Activities in Alzheimer's Disease Patients. Cimenser, A., Hempel, E., Travers, T., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. Germany pubmed.ncbi.nlm.nih.gov

[Effects of multisensory stimulation interventions in brain-damaged patients]. [2008]

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

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

4. England pubmed.ncbi.nlm.nih.gov

Reactions to music, touch and object presentation in the final stage of dementia. An exploratory study. [2019]

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. Switzerland pubmed.ncbi.nlm.nih.gov

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

7. Netherlands pubmed.ncbi.nlm.nih.gov

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

8. Switzerland pubmed.ncbi.nlm.nih.gov

Sensory-Evoked 40-Hz Gamma Oscillation Improves Sleep and Daily Living Activities in Alzheimer's Disease Patients. [2021]