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 a study drug for treating psychosis in patients with Alzheimer’s disease (AD). Conducted globally with approximately 370 participants over 15 weeks, this randomized, double-blind, placebo-controlled study explores a flexible-dose treatment approach. Currently, there are no approved therapies specifically for Alzheimer’s-related psychosis, which affects more than half of individuals with AD. The study drug targets key neurotransmitter systems—serotonin and dopamine—aiming to manage symptoms associated with this condition.
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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 Alzheimer’s disease (AD)
- Have psychosis symptoms
- Psychosis includes symptoms such as hallucinations (seeing or hearing things that others do not) and/or delusions (false beliefs that are strongly held despite evidence to the contrary)
- 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 symptoms of psychosis that are caused by a condition other than Alzheimer’s disease
- Are at risk of harming themselves
- Have recently started or changed certain medications for memory, mood, or thinking (within the past 8 weeks)
- Are currently in the hospital, live in a nursing home, or are unable to get out of bed
- Are taking certain medications that affect the brain and are not able or willing to stop using them during the study
There are extra eligibility requirements for joining the ITI-1284-201 Study. With patient permission, eligible individuals can be referred for participation.
