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Lithium to Prevent or Delay Dementia

Recruiting

This clinical trial will test lithium as a possible treatment that may delay dementia onset or slow its progression in older adults with mild cognitive impairment (MCI). People with MCI are at risk for dementia caused by Alzheimer's disease, which currently has no cure.

Minimum Age Maximum Age Gender Healthy Volunteers
60 Years N/A All No
September 1, 2017
March 31, 2022
80

  • Diagnosis of MCI

  • Major psychiatric illness
  • Major neurological illness (e.g., multiple sclerosis)
  • Contraindication to lithium (e.g., renal insufficiency)
  • Inability to complete neuropsychological testing due to nonremediable impairment such as blindness

Currently, there is no intervention that has shown a clear effect on the progression of Alzheimer's disease. The possible use of lithium, a drug approved to treat mania, depression, and other mental disorders, to prevent or delay Alzheimer's-related dementia is based on past studies that show associations with changes in the brain, including neurogenesis in the hippocampus. That lithium may alter the Alzheimer's trajectory is supported by numerous observational reports showing delay of dementia onset in those treated with it. However, the results of the few human clinical trials of this drug have been mixed.

In this study, participants will be randomly assigned to take either lithium or a placebo, beginning at 150 mg per day, for 2 years. Participants will undergo magnetic resonance imaging and positron emission tomography of the brain, neurocognitive assessment, and blood- and cerebrospinal fluid-based biomarker measurements to investigate the role of lithium as an anti-dementia agent. Researchers want to determine if the drug has potential disease-modifying properties in individuals with MCI, and whether participants who take lithium will have better cognitive function than those taking a placebo.

Name City State Zip Status Primary Contact
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania 15213 Recruiting James Emanuel
412-246-6004
emanuelje@upmc.edu

Ariel Gildengers, MD

  • National Institute on Aging (NIA)

Name Role Affiliation
Ariel Gildengers, MD Principal Investigator University of Pittsburgh

Name Phone Email
James Emanuel 412-246-6004 emanuelje@upmc.edu
Isaac Delozier 412-246-6487 delozierij@upmc.edu

NCT03185208

Evaluation of Brain and Cognitive Changes in Older Adults With MCI Taking Lithium to Prevent Alzheimer Type Dementia