Staten Islanders Caring For Family Members With Alzheimer’s Plus Agitation: Investigational Pharmaceutical Intervention Phase II Clinical Trial Available

We asked the following questions of the researchers in charge of this clinical trial, and below are their responses.  Questions are in bold, answers in italics:

Have there been side effects reported in the Phase I portion of this trial?  

BMS-986368 has been evaluated in earlier-phase clinical studies; however, detailed Phase 1 results (including specific adverse event rates) are not publicly posted. In this Phase 2 study, safety is closely monitored with regular assessments, labs, and adverse-event tracking.

Is there a summary of possible side effects or other risks from this medication? 

Possible risks include side effects from the investigational study medication and risks related to study procedures (blood draws, vital signs, ECGs, questionnaires). Safety is monitored throughout with regular visits, laboratory testing, and adverse-event reporting.

Is there compensation for participants in this study? 

Compensation for time and travel may be available, and the exact amount (if offered) is determined by the study site and reviewed/approved by an ethics committee. Interested caregivers can contact the site for details.

Is this medication based on another medication or is it completely novel? Does it have similar effects to any other pharmaceuticals on the market for ALZ? 

BMS-986368 is an investigational medication with a different mechanism than currently approved Alzheimer’s drugs. It is not a cholinesterase inhibitor (like donepezil) or memantine; it targets FAAH and MAGL enzymes in the endocannabinoid pathway.

Will there be an active placebo used in this study (such as Niacin) or is it a sugar-pill only placebo?  

The study includes a placebo arm using placebo capsules matched in appearance to study drug. We are not using an ‘active placebo’ like niacin.

Has this medication been shown thus far to have any strong side effects, or any potentially life-threatening side-effects? 

We can’t characterize the frequency or severity of side effects from earlier-phase studies in a press release without sponsor-provided published data. In BALANCE-AAD-1, participant safety is monitored closely, including adverse-event reporting and regular health checks and laboratory monitoring.

**Patients and their caregivers considering participating in this research study are advised to carefully read all documents requiring signatures.  As in most clinical trials, there are limitations to liability of the provider of the experimental medication.  As a pharmaceutical, there are always side effects, and researchers will be recording any new effects observed by patients participating.  However, any severe or even debilitating side effects are generally not subject to liability by the manufacturer or provider, as this is a clinical trial.  Patients should be sure they understand the risks along with the possible benefits. 

Below are details new clinical research study now enrolling participants in Staten Island focused on agitation associated with Alzheimer’s disease.

Agitation is a common and challenging symptom for many families caring for loved ones with Alzheimer’s, and this study offers a local research opportunity for eligible adults and their caregivers. The trial is being conducted in Staten Island in partnership with a trusted community pharmacy and research organization.

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Super Health Pharmacy Recruiting Participants for Alzheimer’s Study Evaluating New Treatment for Agitation in Alzheimer’s Disease 

A Research Opportunity for Adults with Alzheimer’s-Related Agitation in Staten Island

STATEN ISLAND, NY — Super Health Pharmacy, in partnership with Hawthorne Health, announced it is now enrolling participants in a Phase 2 clinical research study evaluating the safety and effectiveness of an investigational oral therapy, BMS-986368, for the treatment of agitation in individuals diagnosed with Alzheimer’s disease.

Agitation — which can manifest as increased restlessness, irritability, emotional distress, or aggressive behaviors — is a frequent and challenging symptom among individuals living with Alzheimer’s disease and often significantly impacts quality of life for both patients and caregivers. The study aims to explore whether BMS-986368 can help reduce these symptoms compared to placebo while monitoring safety and tolerability.

Study Overview:

Title: Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368 for the Treatment of Agitation in Participants with Alzheimer’s Disease

ClinicalTrials.gov Identifier: NCT06808984

Sponsor: Celgene Corporation (a Bristol-Myers Squibb company)

Enrollment: Approximately 120 participants across multiple U.S. sites, including our Staten Island location

Eligibility: Ages 55–90 with a confirmed diagnosis of Alzheimer’s disease and clinically significant agitation. Participants must have a caregiver or study partner and be in a stable living environment.

“Agitation in Alzheimer’s disease can be distressing and difficult to manage with current treatment options,” said Risa Ravitz, MD and Principal Investigator. “This study offers a promising opportunity to evaluate a novel investigational medication that may improve symptom control and enhance the quality of life for patients and their caregivers.”

Participants will be randomly assigned to receive one of two doses of the investigational drug or a placebo for a defined period. Throughout the study, trained medical professionals will closely monitor safety, behavioral changes, and symptom improvements using established clinical assessments.

Why This Research Matters:

Alzheimer’s disease affects millions of Americans, and neuropsychiatric symptoms like agitation are among the most common non-cognitive challenges faced by patients and families. Novel treatments under evaluation such as BMS-986368 aim to address this unmet need and expand therapeutic options.

How to Learn More or Participate:

Participants who qualify and enroll will receive study-related care at no cost and may contribute to research that could shape future treatment strategies for Alzheimer’s disease.

Individuals interested in learning whether they may be eligible for the trial are encouraged to contact:

Super Health Pharmacy – Staten Island

929-702-0646 • [email protected]

About Super Health Pharmacy

Super Health Pharmacy is a community-focused full-service pharmacy serving Staten Island and the surrounding area. Known for personalized care and a wide range of services — from prescription fulfillment and immunizations to durable medical equipment, delivery options, and health consultations — Super Health Pharmacy is committed to supporting the wellness needs of patients and families in its neighborhood.

About Hawthorne Health

Hawthorne Health is a clinical research organization focused on expanding access to innovative clinical trials through community-based and pharmacy-anchored research sites. By combining patient-centered care, trusted local partnerships, and modern research infrastructure, Hawthorne Health helps connect participants and caregivers with studies that address meaningful unmet medical needs.

Banner Image: Agitated. Image Credit – geralt