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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a sensory stimulation system to determine its effectiveness for individuals with mild to moderate Alzheimer's disease. Participants will use the system daily at home for up to 12 months. Researchers will assign participants to one of two groups: one using the active system and the other using a sham (inactive) system. Ideal candidates are those who have experienced a decline in memory or cognitive abilities for at least six months. The trial aims to measure improvements in daily activities and mental function over time. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance Alzheimer's treatment options.

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

Research has shown that treatments involving sensory stimulation, like the one under study, appear safe for people with Alzheimer's. For instance, a small study found that using 40Hz audiovisual stimulation daily for two years was safe and might even help slow memory loss, as participants did not experience serious side effects.

Another study examined how gamma sensory stimulation affects brain health and found that this therapy is linked to less damage in the brain's white matter, which is crucial for maintaining brain health.

These findings suggest that sensory stimulation is generally well-tolerated by Alzheimer's patients, with few reports of harmful effects. While more research is needed to confirm these results, the initial findings are promising regarding safety. ^{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 novel approach to treating Alzheimer's disease. Unlike traditional options like medications that target neurotransmitter activity, this system uses sensory stimulation to potentially enhance brain function. It's designed for easy use at home, making it a convenient alternative to more invasive or medication-heavy treatments. This innovative method could pave the way for non-drug interventions that improve quality of life for those with Alzheimer's.

What evidence suggests that the Sensory Stimulation System is effective for Alzheimer's disease?

This trial will compare the effects of an Active Sensory Stimulation System with a Sham Sensory Stimulation System. Studies have shown that gamma sensory stimulation, using light and sound at a specific frequency (40 Hz), may help slow Alzheimer's disease. In one study, patients with mild Alzheimer's safely used this method daily for two years, and some experienced benefits. Another study found that this type of stimulation might help prevent brain tissue loss and reduce harmful proteins linked to Alzheimer's. These early findings suggest that gamma sensory stimulation could be a promising way to slow Alzheimer's symptoms. ^{2 3 6 7 8}

Who Is on the Research Team?

Ralph Kern, MD

Principal Investigator

Cognito Therapeutics

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12552893/

Gamma sensory stimulation in mild Alzheimer's dementia Five mild Alzheimer's disease (AD) patients safely used daily 40 Hz audiovisual stimulation for 2 years. Late‐onset AD (LOAD) patients showed ...

3. 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 ...

4. picower.mit.edu picower.mit.edu/news/small-study-suggests-40hz-sensory-stimulation-may-benefit-some-alzheimers-patients-years

Small study suggests 40Hz sensory stimulation may benefit ... Small study suggests 40Hz sensory stimulation may benefit some Alzheimer's patients for years. Five volunteers continued receiving 40Hz ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0278412

Gamma frequency sensory stimulation in mild probable ... Non-invasive Gamma ENtrainment Using Sensory stimulation (GENUS) at 40Hz reduces Alzheimer's disease (AD) pathology such as amyloid and tau levels, prevents ...

6. 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10789351/

Noninvasive Gamma Sensory Stimulation May Reduce White ... Combined visual and auditory gamma-sensory stimulation treatment is associated with reduced total and regional white matter atrophy and myelin content loss.

8. neurologylive.com neurologylive.com/view/cognito-gamma-sensory-stimulation-leads-preserved-corpus-callosum-structure-alzheimers

Cognito's Gamma Sensory Stimulation Leads to Preserved ... The Spectris device demonstrated preserved corpus callosum structure and correlated sensory-evoked gamma oscillations in patients with Alzheimer disease.