ITI-1284-201 Study
Alzheimer’s Disease
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Open enrollment for Alzheimer's Disease Study
This clinical trial evaluates the efficacy, safety, and tolerability of an investigational drug for treating psychosis in patients with Alzheimer’s disease (AD). Conducted globally with about 370 participants over 15 weeks, this randomized, double-blind, placebo-controlled study explores a flexible-dose treatment approach. Currently, no approved therapies exist for Alzheimer’s-related psychosis, which affects more than half of AD patients. The investigational drug targets key neurotransmitter systems—serotonin and dopamine—offering a potential breakthrough for managing these challenging symptoms.
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Participation involves:
- Randomization 1:1 to receive either the study drug or placebo sublingually, once a day for 6 weeks.
- About 7 visits to the study center and 2 phone calls.
- Regular assessments, including physical examinations, blood tests, questionnaires/interviews (patients and caregivers), and diary completion (caregivers).
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We are looking for patients who are 55 years of age or older and:
- Meet the clinical criteria for AD
- Have psychosis symptoms
- For ≥1 month (at least intermittently) that were not present before AD onset
- That cause disruption in daily living (for the patient and/or caregiver)
- Have a caregiver who can support the patient during the study
- A relative, housemate, close personal friend, or professional caregiver with sufficient contact and knowledge to assist the patient with medication/visit compliance, and provide information on health and symptoms.
Application for Current Clinical Research Study
Research Study
ITI-1284-201 Study: Alzheimer's Disease (AD)
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People cannot take part if they:
- Have psychotic symptoms primarily attributed to a condition other than ADP
- Are at risk of suicidal behavior
- Have been receiving cholinesterase inhibitors, memantine, and/or antidepressant therapy for less than 8 weeks
- Have plans to initiate psychotherapy during the study
- Ongoing; stable (4 weeks) psychotherapy is permissible
- Are hospitalized, receiving skilled nursing care, or bedridden
- Are unable or unwilling to discontinue other drugs with known psychotropic properties or any non-psychotropic drugs with known or potentially significant central nervous system effects.
There are extra eligibility requirements for joining the ITI-1284-201 Study. With patient permission, eligible individuals can be referred for participation.
