CLINICAL TRIAL

Treatment for Mild Cognitive Impairment (MCI)

Recruiting · 65+ · All Sexes · Washington, United States

This study is evaluating whether a new treatment approach called COT might help protect the memory and brain regions of people who are already showing signs of memory loss.

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About the trial for Mild Cognitive Impairment (MCI)

Eligible Conditions
Mild Cognitive Impairment (MCI) · Cognitive Dysfunction · Alzheimer Disease · Early Alzheimers Disease · Memory Disturbances

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 in Phase 2 and have already been tested with other people.

Control Group 1
Sham
DRUG
Control Group 2
COT
DRUG

Eligibility

This trial is for patients born any sex aged 65 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The patient has a MMSE score of 21-27, a CDR score of 1.0 (mild AD), and scores on the Logical Memory II subscale from the Wechsler Memory Scale-Revised within the recommended education-adjusted ranges. show original
The person does not have any signs of infection, stroke, or any other neurological diseases, and they also don't have any significant nasal problems. show original
According to the National Institute on Aging/Alzheimer's Association Guidelines, it is probable that the person has mild AD. show original
with Pittsburgh Compound B (PIB), or an autosomal dominant mutation in APP Individuals with Alzheimer's disease have either cerebrospinal fluid (CSF) Aβ42 levels that are consistent with the disease, as measured via mass spectrometry by C2N, or document an elevated amyloid burden consistent with Alzheimer's disease from positron emission tomography (PET) imaging with Pittsburgh Compound B (PIB), or an autosomal dominant mutation in APP. show original
All participants must have a study partner who is cognitively normal. show original
People between the ages of 65 and 85 years old who are female and have been post-menopausal for at least 2 consecutive years are eligible to participate in this study. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline, 6 months and 9 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline, 6 months and 9 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline, 6 months and 9 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 5 primary outcomes and 9 secondary outcomes in patients with Mild Cognitive Impairment (MCI). Measurement will happen over the course of Baseline and 9 months.

Changes in cortical thickness and grey matter volumes
BASELINE AND 9 MONTHS
Defines as MRI imaging changes of the hippocampus and entorhinal cortex
BASELINE AND 9 MONTHS
Changes in subfield segmentations of the hippocampus and entorhinal cortex
BASELINE AND 9 MONTHS
Using the Automatic Segmentation of Hippocampal subfields looking for changes in the hippocampus and entorhinal cortex
BASELINE AND 9 MONTHS
Changes in the grey matter volumes of other structures of the primary olfactory cortex
BASELINE, 9 MONTHS
Primary olfactory region images will use MPRAGE MRI sequence for grey matter volume
BASELINE, 9 MONTHS
Changes in odor discrimination scores
BASELINE, 9 MONTHS
Odor discrimination score defines patient's ability to detect differences between odors.
BASELINE, 9 MONTHS
Changes in the cortical thickness of other structures of the primary olfactory cortex
BASELINE, 9 MONTHS
Primary olfactory region images will use MPRAGE MRI sequence for cortical thickness
BASELINE, 9 MONTHS
ADCS-PACC composite score
9 MONTHS
Combines tests that assess episodic memory, timed executive function and global cognition. Alzheimer's Disease Cooperative Study (ADCS) PACC (ADAS-PACC) is a composite score of: The Total Recall score from the Free and Cued Selective Reminding Test (FCSRT) (range from 0-48 points), The Delayed Recall score on the Logical Memory IIa subtest from the Wechsler Memory Scale (range from 0-25 points), the Digit Symbol Substitution Test score from the Wechsler Adult Intelligence Scale-Revised (range from 0-93 points), and the MMSE score (range from 0-30 points). Each of the component change scores is divided by the baseline sample standard deviation of that component, to form standardized z scores. These z scores are summed to form the composite. Z Scores could range from -5 to +5 with higher scores indicating less deficit and lower scores indicating greater deficit.
9 MONTHS
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Patient Q & A Section

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

What is mild cognitive impairment (mci)?

In a clinical practice, many of the most common reasons for testing an adult suspected of a primary brain disorder are in fact not pathological but are a consequence of other medical and psychiatric problems. The present investigation indicates that a history of mci (including subjective and objective complaints and psychophysiological disturbances) in these adults is frequently, but not universally, associated with objective and subjective memory deficits.

Anonymous Patient Answer

What are common treatments for mild cognitive impairment (mci)?

Most MCI patients receive preventive medical treatment and counselling. A small number receive cognitive remediation therapy (CRT), particularly in the domains of episodic memory, verbal learning, and processing speed. It is generally used for individuals with MCI who experience persistent, moderate, and severe impairments in the individual's cognitive abilities. While its use is widespread, there is significant controversy over whether or not CRT is effective for modifying cognition in patients with MCI.

Anonymous Patient Answer

What are the signs of mild cognitive impairment (mci)?

In this pilot study of healthy older adults, a number of the signs that clinicians can expect in patients with mci differed from those that have been reported in the clinical research literature. Findings from a recent study will guide the evaluation of the symptoms of mci in the older adult.

Anonymous Patient Answer

How many people get mild cognitive impairment (mci) a year in the United States?

We estimate that an average of 6% of the adult population (aged >55 years) has [mild cognitive impairment] (mci). This is an additional 4 million people with undiagnosed MCI and an additional 2 million people with MCI untreated. MCI prevalence is also more common in females than in males. Additional work will be needed to determine whether or not screening for MCI may improve patient outcomes and reduce healthcare costs for persons with MCI.

Anonymous Patient Answer

Can mild cognitive impairment (mci) be cured?

When a person with mci is prescribed the appropriate medication and has appropriate adherence to the treatment, the chances of experiencing a positive outcome and not experiencing an adverse event are quite high.

Anonymous Patient Answer

What causes mild cognitive impairment (mci)?

Many factors may contribute to mci, including genetic vulnerability, age, and environmental factors such as smoking and air pollution. Some evidence also suggests that the condition may be more common in those who report poorer health, and may be more common than previously thought. There is ongoing work to assess the effect of diet and some medications in Mci.\n

Anonymous Patient Answer

What is the primary cause of mild cognitive impairment (mci)?

In this cohort, the most common causes of [mci]] are Alzheimer's disease (AD) and [depression] whereas amyloid plaque formation and tangle formation are associated with memory decline. However, these common diagnoses may not tell us much about the individual-level pathology in patients with mci.

Anonymous Patient Answer

What does treatment usually treat?

While cognitive impairment is commonplace, most of the people with mild cognitive impairment (mci) report they do not need treatment. However, there is no clear information regarding treatment preferences, effectiveness, and adherence among patients with mci. Therefore, further studies need to be done across countries to further determine the needs and preferences of patients with mci.

Anonymous Patient Answer

What is treatment?

Currently, there is no clear recommendation for treatments for MCI, because of the lack of information on the treatment of MCI and the number of treatments, the variety of MCI, and the differing conceptualizations of MCI, which has made it difficult to set definitive treatment guidelines. The consensus is that MCI can persist for many years and can occur in a variety of brain disorders. Given the heterogeneity of MCI, it is not expected that an exact definition of treatment can be determined; however research is still ongoing. There is a need for a deeper understanding of treatment options through longitudinal studies.

Anonymous Patient Answer

Have there been any new discoveries for treating mild cognitive impairment (mci)?

Researchers should not consider MCI to be an end-stage illness of the brain. New research should focus on how to maintain the brain's ability to function. This might include cognitive, behavioral, and physiological components for healthy aging and mci.

Anonymous Patient Answer

Does treatment improve quality of life for those with mild cognitive impairment (mci)?

Treatment for those in receipt of CCRT was not associated with an increase in QOL. On the contrary, some QOL scores actually declined for those in receipt of CCRT.

Anonymous Patient Answer

What are the common side effects of treatment?

Treatment affected the patients in different ways; some adverse events could only manifest themselves after the conclusion of treatment whereas others only appeared upon completion of the treatment. In some cases, multiple medications were associated with new side effects. Data from a recent study are mostly related to age, sex, underlying disease and treatment used. The prevalence of most of the adverse effects appears to be comparatively low to other patients using different medication classes undergoing similar therapies. There is a lack of conclusive evidence for serious side effects and the existence of safe treatments with which to treat patients with mCI.

Anonymous Patient Answer
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