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New treatment option for Cognitive Impairment
Official title AI-Driven Cognitive Digital Therapeutics for Dementia Management
ClinicalTrials.gov ID: NCT06783465
What this study is testing
- What it's testing
- The study would investigate the effect of a cognitive digital therapeutics system. The intervention group would receive three digital therapeutics sessions per week for 8 weeks, while the control group would receive usual care.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Age at least 50 years old.
- Clinical Dementia Rating from 0.5-1
- Physician diagnosed mild neurocognitive disorder or dementia (according to ICD-11 diagnostic criteria)
You likely can't join if
- Mini-mental state examination score below 18
- If receiving an approved Alzheimer's disease treatment such as acetylcholinesterase inhibitor (AChEIs) or memantine or both for Alzheimer's disease...
- Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant's mild neurocognitive...
- History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening.
- Any psychiatric diagnosis or symptoms (example, hallucinations, major depression, or delusions) that could interfere with study procedures in the...
- Geriatric Depression Scale (GDS) score greater than or equal to 10 at Screening.
See the full eligibility criteria
- Age at least 50 years old.
- Clinical Dementia Rating from 0.5-1
- Physician diagnosed mild neurocognitive disorder or dementia (according to ICD-11 diagnostic criteria)
- Mini-mental state examination score below 18
- If receiving an approved Alzheimer's disease treatment such as acetylcholinesterase inhibitor (AChEIs) or memantine or both for Alzheimer's disease, must be on a stable dose for at least 4 weeks prior to Baseline.
- Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant's mild neurocognitive disorder or dementia.
- History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening.
- Any psychiatric diagnosis or symptoms (example, hallucinations, major depression, or delusions) that could interfere with study procedures in the participant.
- Geriatric Depression Scale (GDS) score greater than or equal to 10 at Screening.
- Participants who were dosed in a clinical study involving any new chemical entities for AD within 6 months prior to screening unless it can be documented that the participant was in a placebo treatment arm.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei City, Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei City, Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.