Bonita Springs, FLNCT06651567Now EnrollingIRB Ready

Alzheimer's Dementia Clinical Trial in Bonita Springs, FL

Access cutting-edge alzheimer's dementia treatment through this phase 2 clinical trial at a research site in Bonita Springs. Study-provided care at no cost to qualified participants.

Sponsored by Intra-Cellular Therapies, Inc.

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Expert Care in Bonita Springs

Access alzheimer's dementia specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related alzheimer's dementia treatment provided free

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Check if you qualify for this alzheimer's dementia clinical trial in Bonita Springs, FL

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Bonita Springs

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Bonita Springs site if eligible
  4. 4Begin participation

About This Alzheimer's Dementia Study in Bonita Springs

This is a multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of the efficacy, safety, and tolerability of ITI-1284 in patients with agitation associated with Alzheimer's dementia

Sponsor: Intra-Cellular Therapies, Inc.

Who Can Participate

Inclusion Criteria

Can understand the nature of the trial and protocol requirements and provide signed informed consent, if in the judgement of the Investigator is deemed competent to provide consent or if patient is deemed not competent to provide informed consent, with the patient's assent (if capable), consent may be provided by an appropriate person (eg, patient's Legally Authorized Representative \[LAR\]) before the initiation of any study-specific procedures in accordance with local regulations;
Meets clinical criteria for Alzheimer's disease based on 2011 National Institute of Aging-Alzheimer's Association (NIA-AA) dementia criteria and biomarker criteria and either:
Has a high likelihood for amyloid pathology consistent with Alzheimer's disease, as confirmed by blood-based biomarker at Screening as detected by an appropriately validated test; or
Has historical documentation of cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan;
Meets all criteria for agitation according to the International Psychogeriatric Association (IPA) consensus definition
Has clinically meaningful agitation defined as a Neuropsychiatric Inventory-Agitation/Aggression (NPI-AA) domain total score of ≥ 4 at both Screening and Baseline;
CGI-S score ≥ 4 at Screening and Baseline;
Has Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 at Screening;

Exclusion Criteria

Agitation symptoms are attributable to concomitant medications, adverse environmental conditions, substance abuse, or active medical or psychiatric conditions as per Investigator's judgment;
Has been diagnosed with one or more of the following psychiatric conditions:
Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia;
Bipolar disorder;
Major depressive disorder, unless it is considered stable and treated for at least 8 weeks prior to Screening;
Has a significant risk for suicidal behavior during the course of their participation in the study, or is considered to be an imminent danger to themselves or others, in the opinion of the investigator, and/or as assessed by Columbia Suicide Severity Rating Scale (C-SSRS); or the patient has had 1 or more suicide attempts within the 2 years prior to Screening;
The patient has known hypersensitivity or intolerance to ITI-1284 or lumateperone, or to any of their excipients.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bonita Springs?

Yes, this clinical trial (NCT06651567) has an active research site in Bonita Springs, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Alzheimer's Dementia Treatment Options in Bonita Springs, FL

If you're searching for alzheimer's dementia treatment options in Bonita Springs, FL, this clinical trial (NCT06651567) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bonita Springs research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced alzheimer's dementia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all alzheimer's dementia clinical trials near you to find additional studies recruiting in your area.

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