Lewy Body Dementia Psychosis study: ACP-204
Official title Phase 3, Open Label Extension Study of ACP-204 in Lewy Body Dementia Psychosis
ClinicalTrials.gov ID: NCT07095465
What this study is testing
What is ACP-204?
an investigational oral capsule being studied as a potential treatment for Lewy Body Dementia Psychosis
Also referred to as ACP-204 Tartrate.
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
- The study continues to evaluate ACP‑204 in adults with Lewy Body Dementia Psychosis.
- Who it's for
- Adults diagnosed with Lewy Body Dementia Psychosis.
- What's involved
- Participants will receive ACP‑204 and attend scheduled study visits.
- Time commitment
- The study lasts 52 weeks with regular visits as scheduled.
- Phase 3: a large, late-stage study
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
- The subject may benefit from long-term therapy with open-label ACP-204 treatment in the judgment of the Investigator
- Subject has completed Visit 6 (EOT) of the antecedent ACP-204-012 study and did not have an early discontinuation from the antecedent study
- Can complete all study visits with a study partner/caregiver
- The subject's LAR (or study partner/caregiver, if local regulations allow) must provide written informed consent.
- The subject must provide written (if capable) informed assent per local regulations
You likely can't join if
- Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason
- Is in hospice, is receiving end-of-life palliative care, or is bedridden
- Has a heart rate \<50 beats per minute, as measured by vital signs at Baseline (EOT visit of the antecedent study).
- Has a BMI \<18.5 kg/m2 or known unintentional weight loss ≥7% of body weight over past 6 months
- jeopardize the safe participation of the subject in this study; OR
- interfere with the conduct or interpretation of safety or how well it works evaluations in the study
See the full eligibility criteria
- The subject may benefit from long-term therapy with open-label ACP-204 treatment in the judgment of the Investigator
- Subject has completed Visit 6 (EOT) of the antecedent ACP-204-012 study and did not have an early discontinuation from the antecedent study
- Can complete all study visits with a study partner/caregiver
- The subject's LAR (or study partner/caregiver, if local regulations allow) must provide written informed consent.
- The subject must provide written (if capable) informed assent per local regulations
- If the subject is a female, she must be of nonchildbearing potential
- Refrain from donating sperm, AND
- Either
- Be abstinent from sexual intercourse where pregnancy can occur (abstinent on a long-term and persistent basis) and agree to remain abstinent OR
- Use a condom and subject's female partner (if of childbearing potential and not pregnant) must use an additional contraceptive method
- Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason
- Is in hospice, is receiving end-of-life palliative care, or is bedridden
- Has a heart rate \<50 beats per minute, as measured by vital signs at Baseline (EOT visit of the antecedent study).
- Has a BMI \<18.5 kg/m2 or known unintentional weight loss ≥7% of body weight over past 6 months
- jeopardize the safe participation of the subject in this study; OR
- interfere with the conduct or interpretation of safety or how well it works evaluations in the study
- Is actively suicidal at Visit 1 (Baseline, EOT visit of the antecedent study)
- Has a neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that, in the judgment of the Investigator, would...
- Requires treatment with a medication or other substance that is prohibited by the protocol or will be used in a way that violates a use restriction
The study team makes the final eligibility decision.
Where it is enrolling
- Irvine, California, United States
- Washington D.C., District of Columbia, United States
- Aventura, Florida, United States
- Boca Raton, Florida, United States
- Lady Lake, 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
- Columbus, Ohio, United States
- Tulsa, Oklahoma, United States
- Cypress, Texas, United States
- San Antonio, Texas, United States
- Stafford, Texas, United States
- Richmond, Virginia, United States
- Kirkland, Washington, United States
- Cherven Bryag, Bulgaria
- Sofia, Bulgaria
- Varna, Bulgaria
+ 12 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, but 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?
This study is enrolling now at Irvine, California, United States; Washington D.C., District of Columbia, United States; Aventura, Florida, United States; Boca Raton, Florida, United States; Lady Lake, Florida, United States; Miami, Florida, United States and 26 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.