Axovant Study

Study Type

Cognitive Impairment & Alzheimer's Disease

Study Purpose

The purpose of the AXOVANT research study is to evaluate the investigational drug RVT-101 and its effect on patients living with mild to moderate Alzheimer’s disease. The study will assess the improvement of patients’ ability to perform daily living activities and cognitive function over time, and will evaluate the safety and tolerance of patients while on the medication.

The effects of the drug versus a placebo will be measured in subjects currently receiving a stable dose of donepenzil therapy.

About the Study

Over a period of eight months, study participants and their partners/caregivers will undergo a series of nine visits to Pennington Biomedical for assessment and observation. Visits to Pennington Biomedical will take place once every three weeks and will last approximately four to five hours each.

Members of the study team will remain in contact with participants throughout the study to ensure they are taking the medication as instructed, as well as to discuss any reactions to the drug.

Participants may continue to take current prescription medications and maintain other medical practices outside of the clinical trial, such as assisted living care.

Study Design

Number of Visits:

  • 9 study visits

Procedures:

  • Physical and Neurological examinations
  • Electrocardiogram
  • Multiple questionnaires
  • Blood Tests
  • Vital signs
  • MRI

Study Qualifications

To qualify, participants in this study should be:

  • Between the ages of 50 and 85 years old
  • Have a diagnosis of probable Alzheimer’s disease
  • Have a clear history of functional and cognitive decline over at least one year
  • Able to ingest a whole pill in tablet form
  • Taking a prescriptive medication (donepezil) for at least four months
  • Have a trial partner/caregiver who is able to be with the participant at least three days each

week for a minimum of ten hours each week while the participant is awake. The trial partner/caregiver should also be able to attend all study visits with the participant and be able to answer questions about the participant.

Study Duration

Participation in this study will last approximately eight months (9 total study visits).

Compensation

Total compensation for the completion of this study is $450.

Study Contact

If you are interested in volunteering for this research study, call 225-763- 2973 or e-mail: dementia@pbrc.edu.

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