Skip to main content
U.S. flag

An official website of the United States government

Here's how you know

Here's how you know

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS
A lock (  ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

Find more clinical trials

Treatment of Psychosis and Agitation in Alzheimer's Disease

Start: June 2014
End: January 2020
Enrollment: 80

What Is This Study About?

This Phase II clinical trial will test low-dose lithium as a treatment for psychosis and agitation in older adults with Alzheimer's disease. Currently, there is no federally approved medication for the treatment of psychosis or agitation in Alzheimer's. Safety, side effects, and efficacy will be evaluated.

Do I Qualify To Participate in This Study?

Minimum Age: N/A

Maximum Age: N/A

Must have:

  • Diagnosis of possible or probable Alzheimer's disease by standard NIA criteria
  • Mini-Mental State Examination score of 5-26
  • Neuropsychiatric Inventory agitation/aggression subscale score of more than 4 (moderate to severe symptoms)
  • Female participants must be postmenopausal
  • Availability of a study partner

Must NOT have:

  • Medical contraindication to lithium treatment or prior history of intolerability to lithium treatment
  • Contraindications to lithium, including resting tremor causing functional impairment, history of falls in the last month, untreated thyroid disease or any abnormal thyroid function test, creatinine level > 1.5 mg/100ml or a glomerular filtration rate < 60 ml/min/ 1.73m2, blood pressure > 150/90 mm Hg; heart rate < 50 bpm
  • Unstable cardiac disease based on history, physical examination, and ECG
  • Taking medications that, in combination with lithium, are known to have adverse renal effects, including therapeutic or higher doses of diuretics (for example, hydrochlorothiazide greater than 25 mg daily or furosemide greater than 10 mg daily).
  • Whenever feasible, participants taking antidepressants or antipsychotics will be washed off these medications for at least 24 hours before starting lithium. Those who do not wish to discontinue these medications will be allowed to enter the trial provided there is no contraindication to concomitant lithium use with that specific psychotropic medication. During the trial, subjects will be permitted to receive lorazepam as needed up to 2 mg/day for anxiety/insomnia and non-benzodiazepine hypnotics such as zolpidem.
  • Current clinical diagnosis of schizophrenia, schizoaffective disorder, other psychosis, or bipolar 1 disorder
  • Current or recent (past 6 months) alcohol or substance dependence
  • Current major depression or suicidality as assessed by the study psychiatrist
  • Suicidal behavior or dangerous behavior with serious safety risk or risk of physical harm to self or others
  • Parkinson's disease, Lewy body disease, multiple sclerosis, central nervous system infection, Huntington's disease, amyotrophic lateral sclerosis, other major neurological disorder
  • Clinical stroke with residual neurological deficits
  • Other acute, severe, unstable medical illness (cancer patients with active illness or metastases will be excluded, but past history of successfully treated cancer will be considered)
  • QTc interval > 460 ms at the time of baseline
  • Hypematremia as determined by serum level > 150 meq/L

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Who Sponsors This Study?

Lead: New York State Psychiatric Institute

Collaborator Sponsor

  • National Institute on Aging (NIA)

Source: ClinicalTrials.gov ID: NCT02129348

alzheimers.gov

An official website of the U.S. government, managed by the National Institute on Aging at the National Institutes of Health