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Alzheimer’s with Agitation


About the Study

If your loved one is suffering from Alzheimer’s disease, there is hope. Medical and non-profit organizations are working tirelessly to find treatments and a cure. Part of the process of discovering effective treatments for Alzheimer’s are clinical trials. These research studies and clinical trials are separated into phases, and are offered to patients with Alzheimer’s after pre-clinical trials and early phase studies are completed. 

An Alzheimer’s clinical trial offers patients the opportunity to receive care from some of the nation’s leading neurologists, and includes treatment and continued monitoring at no cost to the patient, with expenses for time and travel potentially reimbursed as well. 

The Fort Wayne Neurological Research Center is currently enrolling for a clinical study to test the effectiveness of a potential new medical option for individuals experiencing agitation associated with Alzheimer’s disease. Symptoms of agitation, aggression or irritability are often associated with Alzheimer’s disease and our clinical trial is currently enrolling individual’s ages 65-90 years old who may be experiencing these symptoms.

If your loved one experiences agitation with Alzheimer’s disease, please review the qualification criteria and submit a form to find out if they are eligible for this study. 

Inclusion Criteria

You may qualify for the Alzheimer's with Agitation study if you must meet the following criteria.

Condition: Alzheimer’s with Agitation

Age: 65-90

Gender: Male or Female

  1. Diagnosis of probable Alzheimer’s disease (AD) based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria.
  2. Clinically significant agitation, at the time of screening and for at least 2 weeks prior to randomization, that interferes with daily routine activities and for which a prescription medication is deemed indicated.

Caregiver must be:

  • Family member who has been providing care to the patient for at least 3 months prior to Screening.
  • Knowledgeable of the patient, and reliable in providing care to the patient.
  • In regular contact with the patient and spend a minimum of 16 hours per week (a minimum of 4 hours on 4 separate days) with the patient.
  • Capable, in the opinion of the investigator, of providing an adequate rating of the patient’s condition.    

Caregiver must also:

  • Be able and willing to communicate with site personnel and to comply with all required study procedures including not administering any prohibited medications during the course of the study, and to oversee the patient’s compliance with the study treatment.
  • Agree to accompany the patient to all site visits, be available by telephone at designated times, and be able and willing to observe for possible adverse events and to report on the patient’s status. 
  • Fully understand the length of the trial.
  • Agree to undergo training in recognizing agitation symptoms and in rating of the scales used in the study.

Exclusion Criteria

If some of the following apply, you MAY NOT qualify for this study.

  • Caregiver is unwilling or unable, in the opinion of the investigator, to comply with study instructions.
  • Patient has dementia predominantly of non-Alzheimer’s type (e.g., vascular Dementia, Parkinson’s disease, substance-induced dementia).      
  • Patient is hospitalized in a mental health facility (e.g., psychiatric hospital or ward) or living alone.                                         
  • Patient has symptoms of agitation that are not secondary to Alzheimer’s Disease (e.g., pain, other psychiatric disorder or delirium due to a metabolic disorder, systemic infection or substance induced).  

Principle Investigator

Neurologist Leading The Study

See if you qualify for this study

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Email *

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Study Brochure

Resources and Clinical Research Studies for patients with Alzheimers with Agitation.

Additional Resources

Resources for Alzheimer Patients & Caregivers

We know that an Alzheimer’s diagnosis is a challenging prospect to face. We’re here to help. We want to provide you with every available resource to equip and help you on your health journey. We’ve created a list of organizations that are actively working to find answers, provide information, discover new treatments, and who are relentlessly advocating on your behalf.

Their mission is to rid the world of Alzheimer’s disease. It’s ambitious, but they are actively pursuing every avenue to accomplish it. Armed with care and support for families affected by Alzheimer’s, funding research, and leading the way with advocacy, Alzheimer’s Association is making an impact against Alzheimer’s Disease Dementia. They have a 24/7 hotline with clinicians who can give information and referrals to people affected by Alzheimer’s.

Visit Website:

Dementia Care Central is an educational resource for anyone affected by dementia, Alzheimer’s included.  They offer resources for learning more about dementia and Alzheimer’s, and include support resources for caregivers of dementia patients.

Visit Website:

Alzheimer’s Drug Discovery Foundation is a resource entirely committed to finding treatments and cures for Alzheimer’s. They offer patients and caregivers the latest information in research, drug discovery, and medical advances in Alzheimer’s treatments.

Visit Website:

ALZ Connected is a free online forum for anyone affected by Alzheimer’s Disease. They offer connections that allow people to share their personal experiences with one another to better support those who are affected by Alzheimers’. Their online community helps people know they are not alone in their battle against Alzheimer’s.

Visit Website: