Clinical Trial 55459

New York, NY 10128


Summary:

Healthcare systems in the United States face an ongoing surge in older adults with U.S. Census data indicating that the number of Americans over the age of 65 will nearly double between 2010 and 2030. The care of mental health and neurological health in the elderly has emerged as an important consideration as the population of the United States ages. It is thought that around 10% of elders in the United States have depression and this number is even higher in individuals with mild cognitive impairment (MCI), of which ~40% experience depression. Further, there is evidence that patients with a combination of MCI and depression do worse, with more severe behavioral symptoms, worse functioning, increased risk of advancement to dementia, and higher healthcare costs. It remains unclear how much benefit traditional antidepressants provide for depressive symptoms in patients with cognitive impairment. Therefore, there is still a need for novel treatments that can improve depression in individuals with MCI.



Criteria:

Inclusion Criteria

  1. Written informed consent (and assent when applicable) obtained from subject or subject’s legal representative and ability for subject to comply with the requirements of the study.

  2. Age 50-90 years

  3. Participant in good physical health

  4. Participants may be on medications for depression as long as they remain on a stable dose

  5. Montgomery Asberg Depression Rating Scale (MADRS) ≥ 20

  6. A clinical diagnosis of mild cognitive impairment (MCI) or Mild Alzheimer’s Disease

  7. Montreal Cognitive Assessment (MoCA) ≥ 18

  8. Global Clinical Dementia Rating (CDR) ≤ 1

  9. Women of child-bearing potential must have a negative pregnancy test at screening and prior to ketamine infusion

Exclusion Criteria

  1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.

  2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

  3. Serious unstable medical illness

  4. Uncontrolled hypertension

  5. Abnormal electrocardiogram (ECG) findings

  6. Renal impairment defined as BUN 20 mg/dl and/or Creatinine clearance of > 1.3

  7. Current drug or alcohol use disorder

  8. History of seizures without a clear and resolved etiology

  9. Lifetime history of schizophrenia, schizoaffective disorder, bipolar I or II disorder

  10. Presence of psychotic symptoms or lifetime psychotic disorder

  11. Recreational ketamine or phencyclidine use in the last 2 years

  12. BMI > 40

  13. Serious and imminent suicidal or homicidal risk determined by CSSRS and clinician interview

  14. SBP > 165 or DBP > 95 on infusion day


Qualified Participants May Receive:

1 - IV ketamine infusion 

Compensation up to $750


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.