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Tests treatment safety and results for Lewy Body Dementia Psychosis
Official title Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis
ClinicalTrials.gov ID: NCT07029581
What this study is testing
What is ACP-204?
ACP-204 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for lewy body dementia psychosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 84
You may be able to join if
- Male or female ≥55 years to \<85 years of age at the Screening visit living in the community or, if permitted by local regulations, in an...
- Can provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must...
- The subject's LAR must provide written informed consent.
- The subject must provide written (if capable) informed assent per local regulations.
- Meets either the clinical criteria for Parkinson's disease with dementia as defined by the Movement Disorder Society's Task Force or the revised...
You likely can't join if
- Is in hospice, is receiving end-of-life palliative care, or is bedridden
- Has psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition (e.g. schizophrenia...
- Is actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline)
- Has a history or current evidence of a serious and/or significant unstable cardiovascular, respiratory, endocrine, gastrointestinal, renal, hepatic...
- Has other clinically significant CNS abnormalities that are most likely contributing to the dementia or findings on MRI or CT
See the full eligibility criteria
- Male or female ≥55 years to \<85 years of age at the Screening visit living in the community or, if permitted by local regulations, in an institutionalized setting
- Can provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met:
- The subject's LAR must provide written informed consent.
- The subject must provide written (if capable) informed assent per local regulations.
- Meets either the clinical criteria for Parkinson's disease with dementia as defined by the Movement Disorder Society's Task Force or the revised clinical criteria for probable dementia with Lewy bodies (DLB) by...
- Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association
- Is in hospice, is receiving end-of-life palliative care, or is bedridden
- Has psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition (e.g. schizophrenia, bipolar disorder, delusional disorder) other than dementia
- Is actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline)
- Has a history or current evidence of a serious and/or significant unstable cardiovascular, respiratory, endocrine, gastrointestinal, renal, hepatic, hematologic, immunologic, genitourinary, psychiatric or neurologic...
- Has other clinically significant CNS abnormalities that are most likely contributing to the dementia or findings on MRI or CT
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
- Washington D.C., District of Columbia, United States
- Aventura, Florida, United States
- Boca Raton, Florida, United States
- Clermont, Florida, United States
- Gainesville, Florida, United States
- Lady Lake, Florida, United States
- Maitland, Florida, United States
- Miami, Florida, United States
- West Palm Beach, Florida, United States
- Honolulu, Hawaii, United States
- Kansas City, Kansas, United States
- Commack, New York, United States
- Chapel Hill, North Carolina, United States
- Columbus, Ohio, United States
- Tulsa, Oklahoma, United States
- Abington, Pennsylvania, United States
- Cypress, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
+ 26 more site(s).
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, 55 years to 84 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States; Washington D.C., District of Columbia, United States; Aventura, Florida, United States; Boca Raton, Florida, United States; Clermont, Florida, United States; Gainesville, Florida, United States and 40 more location(s). 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.