Treatment for Mild Cognitive Impairment (MCI)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Icahn School of Medicine at Mount Sinai, New York, NY
Mild Cognitive Impairment (MCI)+2 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether light delivered at 40 Hz can improve sleep and cognition in people with mild cognitive impairment.

See full description

Eligible Conditions

  • Mild Cognitive Impairment (MCI)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Mild Cognitive Impairment (MCI)

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 2 secondary outcomes in patients with Mild Cognitive Impairment (MCI). Measurement will happen over the course of 1 hour after intervention.

1 hour after intervention
Cognition using a working memory task
Electroencephalography (EEG) power at 40 hertz (Hz)
Subjective Sleepiness using the Karolinska Sleepiness Scale (KSS)

Trial Safety

Safety Progress

1 of 3

Other trials for Mild Cognitive Impairment (MCI)

Trial Design

2 Treatment Groups

Active Tailored Rhythmic Lighting
1 of 2
Inactive Placebo Rhythmic Lighting
1 of 2
Active Control
Non-Treatment Group

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Inactive Placebo Rhythmic Lighting
Device
1 hour intervention period where an inactive, placebo lighting condition is experienced by participants.
Active Tailored Rhythmic Lighting
Device
1 hour intervention period where active lighting is experienced by participants.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 hour after intervention
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 hour after intervention for reporting.

Who is running the study

Principal Investigator
M. F.
Prof. Mariana Figueiro, Professor, Population Health Science and Policy
Icahn School of Medicine at Mount Sinai

Closest Location

Icahn School of Medicine at Mount Sinai - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
For the age-matched healthy controls, participants must not have been diagnosed with mild cognitive impairment or Alzheimer's disease-related dementias (having a MoCA score above 25). show original
People who participate in the study must have a score of five or less on the Pittsburgh Sleep Quality Index. show original
People with amnestic mild cognitive impairment or mild Alzheimer's disease, as defined by a Montreal Cognitive Assessment (MoCA) score between 17 and 25, can participate in this study. show original

Patient Q&A Section

What are the signs of cognitive decline?

"There is a decrease in brain volume and white/gray matter ratio. The most common site of change is the hippocampus. The other most common brain structures affected were the parietal lobe and amygdala." - Anonymous Online Contributor

Unverified Answer

What is cognitive decline?

"Elderly individuals without cognitive impairment have a normal risk for developing cognitive impairment. Early detection of cognitive decline and further investigation of its underlying pathophysiological mechanisms are warranted." - Anonymous Online Contributor

Unverified Answer

What causes cognitive decline?

"The present study indicates that neuropsychiatric disturbances are a key factor in explaining cognitive impairments. It is not only the dementias themselves that are at risk of cognitive decline but also disorders in the brain. Cognitive impairments can have considerable impact on functional abilities." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cognitive decline?

"Most strategies aimed at improving cognitive functioning are used often and in many people with cognitive decline, with varying degrees of success. A number of strategies offer no improvement, however, and other strategies do so with varying degrees of success. In general it is recommended that cognitive therapists do seek to help people with cognitive decline and to evaluate the impact of the various strategies they are undertaking; that interventions that show promise on measures such as delayed recall tests should be validated qualitatively; and that pharmacological interventions and supplements (such as ginkgo biloba or acetyl-L-carnitine) should be used within their approved indications according to evidence-based practice guidelines." - Anonymous Online Contributor

Unverified Answer

How many people get cognitive decline a year in the United States?

"The percentage of Americans age 65 years and older who experience moderate-to-severe cognitive decline in the 12 months or the previous year has increased significantly, from 6% in 1990-1991 to 15% in the 2005-2006 survey. The prevalence of moderate-to-severe cognitive decline increased at a much faster rate than the prevalence of mild cognitive impairment. Findings from a recent study suggest that the increase in the prevalence of cognitive decline has largely been driven by an increase in more-severe cognitive decline." - Anonymous Online Contributor

Unverified Answer

Can cognitive decline be cured?

"A major obstacle to cures for Alzheimer disease and some forms of dementia is our incapability to identify when people will be demented. If there are effective treatments for neurodegenerative dementia then one of them likely will be to halt cognitive decline in the early stages. Our models and analysis of the clinical literature suggest that cognitive decline may be modifiable." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for cognitive decline?

"Most patients with mild cognitive impairment (MCI) do not show cognitive worsening or conversion to Alzheimer's disease within a year. In this group of patients, trials were not beneficial with respect to cognitive outcomes. However, there may be a subgroup of MCI patients with cognitive worsening, who may benefit from placebo-controlled protocols. We suggest that such patients must remain under careful longterm observational followup." - Anonymous Online Contributor

Unverified Answer

Does treatment improve quality of life for those with cognitive decline?

"In this sample of older people with mild-to-moderate cognitive declines, the cognitive improvement achieved by the active treatment group was associated with an improvement in physical and mental QOL. In a recent study, findings support the value of active treatment for cognitive decline and may have a positive implication for the future of brain ageing research." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of cognitive decline?

"Even though primary degenerative neuro-cognitive symptoms could not be defined in the majority of cases, a variety of neuro-cognitive consequences of CCSVI was evident in our sample. It is suggested that primary degenerative vascular-cognitive symptoms are unlikely to be a primary feature of CCSVI. Although the findings could be of importance in assessing patients' disease-related outcomes, further studies are needed to determine whether treatment may result in improvement or deterioration of primary degenerative neuro-cognitive symptoms of CCSVI." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating cognitive decline?

"Since [2010] (when the last update to the NACC was published in "Neurology"), it appears to us that very few new treatments for cognitive decline have been identified and in few circumstances have their mechanisms of action been elucidated. This is not surprising given that there is significant competition between the pharmaceutical industry for the development of new treatments for dementia and that the [2013] USFDA labeling for cholinesterase inhibitors [donepezil (INN), rivastigmine (USAN)] required many [clinicians] and [manufacturers] to show that these drugs had not been effective for [over three years]." - Anonymous Online Contributor

Unverified Answer

What does treatment usually treat?

"Cognitive and behavioral therapies can help most people with mild to mild dementia, but not other types. This may be because treating dementia involves dealing with loss by losing abilities that are important for daily living, not because treatments deal with the actual symptoms that dementia causes. In contrast, medications can help some people with dementia feel better as well as preventing worsening of symptoms and improving daily functioning. As with any medication therapy, treatment should be tailored to the person's needs. There isn't a "best approach" to slowing down or stopping cognitive and behavioral symptoms. Instead, treatment should be individualized." - Anonymous Online Contributor

Unverified Answer

What is the latest research for cognitive decline?

"There is a need for research on the cause and the effect of cognitive decline. Specifically, researchers need to more fully understand the causes of normal cognitive ageing as they seek to identify ways in which older people can be maintained in their homes, families, and communities by utilizing strategies such as cognitive training and the prevention and treatment of mood disorders." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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