Clinical Trials

Clinical trials test interventions, such as drugs or devices, as well as diet or lifestyle changes. Drug testing is the focus of many clinical trials. Clinical trials are the primary way that researchers find out if a promising treatment is safe and effective in people.

Senior Couple On Autumn Walk In Countryside Together

 

CBD Study:

Caring for Behavioral Symptoms of Dementia (CBD): Open-Label Trial of Cannabidiol for the Treatment of Behavioral Symptoms in Older Adults with Alzheimer’s Dementia

Summary:

  • This is a Mclean Hospital study
  • The investigational drug is cannabidiol [CBD] 
  • The study lasts 8 weeks

Eligibility Requirements:

  • You can participate in this study if you meet all of the following criteria:

    • You have a diagnosis of Alzheimer’s disease

    • You are experiencing anxiety symptoms regularly

    • You are 55-90 years old

    • You have a study partner with whom you spend at least 10 hours per week, who is able to attend study visits with you

    • You are able to provide informed consent (in the case you are unable to provide consent for yourself, you have someone willing to consent on your behalf)

    • You speak English

You are NOT eligible if:

• You have any serious, unstable medical illness or a seizure disorder

• You have ever been diagnosed with bipolar disorder, schizophrenia, schizoaffective disorder, or a personality disorder

• You currently use cannabinoid products more than once per month

• You are allergic to coconut (the base of the product is coconut oil)

• You are currently taking an anti-epileptic medication, or another medication that is a strong inhibitor or inducer of CYP3A4 or CYP2C19 which is known to interact with CBD (the study doctor will review the list of prohibited medications with you before starting the study)

Effects of NR: Effects of Orally Administered Nicotinamide Riboside on Bioenergetic Metabolism, Oxidative Stress and Cognition in Mild Cognitive

Summary:

  • This is a five year study
  • The investigational drug is Nictomide Riboside vs. placebo
  • Participants will be assessed every 6 weeks up to 12 weeks and then in periods of every 6 months
  • Will have opportunities for brief follow-up remotely in addition to in-person

Eligibility Requirements:

  • Are you experiencing any of the following mental symptoms:

    • Problems with memory or thinking clearly?
    • Trouble remembering details of recent events or conversations?
    • Difficulty doing mental math?
    • More trouble doing complex daily tasks, such as planning dinner for friends or paying bills?
    • Trouble finding the right words in conversation?

    Feeling less motivated or interested in social activities?

You are NOT eligible if:

    • Schizophrenia or schizoaffective disorder?
    • Bipolar disorder, depression or anxiety? If yes, ask follow-up questions to determine eligibility.
      • Clinically unstable mood or anxiety disorder within the last 6 months.
    • Mitochondrial disorder?
    • Dementia (other than Alzheimer’s disease)?
    • History of seizure within the past 10 years?
    • Stroke or transient ischemic attack in the past 12 months?

    Do you have any current cancers or a history of cancer? If so, what is the diagnosis and when was it made?

Please contact Dean Sheppard, sheppard@bu.edu for more information. 

Email: sheppard@bu.edu