What side effects are associated with this type of intervention?

Computerized Cognitive Training Protocols for Mild Cognitive Impairment (MCI) generally have minimal side effects. Participants may experience temporary frustration or fatigue due to the mental effort required. Other common non-pharmacological treatments, such as cognitive behavioral therapy, also have low risk of adverse effects but may occasionally lead to increased anxiety or stress during initial sessions. Overall, these interventions are considered safe and well-tolerated compared to pharmacological treatments, which can have more significant side effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of cognitive impairment, primarily focusing on Alzheimer's disease, such as donepezil and memantine. These drugs aim to improve cognitive functions and slow the progression of symptoms. However, for Mild Cognitive Impairment (MCI), there are no specific FDA-approved medications. Instead, non-pharmacological interventions like cognitive training and rehabilitation are often recommended. The Computerized Cognitive Training Protocol, which involves structured, computer-based exercises to enhance cognitive functions, aligns with these non-drug approaches and represents a promising area of study for improving cognitive outcomes in individuals with MCI.

What other types of research exist?

Promising alternatives to Computerized Cognitive Training Protocol for Mild Cognitive Impairment patients include: 1) Augmentative communication strategies such as the Picture Exchange Communication System (PECS) and other flexible communication systems using photographs, pictures, and video/voice output. 2) Social skills instruction, which has shown short-term improvements in social competence and friendship quality. 3) Nonpharmacological interventions like exercise programs, mindfulness-based stress reduction, and music therapy, which have demonstrated benefits in cognitive and emotional well-being.

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Behavioral Intervention

Cognitive Computerized Training for Cognitive Impairment (CCT Trial)

N/A

Recruiting

Led By Kirk R Daffner, MD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 25-65 years old

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a computer-based training program to help people with cognitive decline improve their memory and thinking skills by doing mental exercises regularly.

Who is the study for?

This trial is for adults aged 25-65 with attention and executive functioning issues or mild cognitive disorders from brain injuries at least a year old. Participants must speak English, be able to visit Brigham and Women's Hospital in Boston for assessments, have internet access, and provide an informant to report on their daily functioning.

What is being tested?

The study examines how well people with cognitive impairments due to brain injury can improve after doing intensive computerized cognitive training. It looks at what factors make the training more effective over a period of 12 months.

What are the potential side effects?

Since this trial involves non-invasive computerized cognitive exercises, there are no direct physical side effects like you'd expect from medication. However, participants may experience mental fatigue or frustration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 25 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in BDNF Levels in blood and saliva

Changes in cognitive outcome measures

Secondary study objectives

Anxiety

Depression

Feelings about cognitive/thinking skills

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Computerized Cognitive TrainingExperimental Treatment1 Intervention

See section of intervention/treatment for additional information.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Mild Cognitive Impairment (MCI), such as Computerized Cognitive Training Protocols, work by engaging participants in structured, computer-based exercises aimed at improving cognitive functions. These interventions enhance neuroplasticity, improve working memory, attention, and executive functions, and may delay the progression to dementia. For MCI patients, these treatments are crucial as they help maintain cognitive abilities, improve daily functioning, and enhance overall quality of life.