NCT06069843 · Phase 2 · ACTIVE NOT RECRUITING
Single-dose Ketamine Treatment to Improve Depression in Mild Cognitive Impairment
This small study gives one intravenous dose of ketamine to adults with mild cognitive impairment and depression. Researchers want to see if it is tolerated and whether it eases depression and thinking problems. It is a Phase 2 pilot, open-label, meaning everyone knows they get the drug. It is early testing, not proven or approved for this use.
You may qualify if
- Age 50-90
- Able to give consent
- Montgomery Asberg Depression Rating Scale (MADRS) score of ≥20 consistent with at least "moderate depression"
- Clinical diagnosis of mild cognitive impairment or mild Alzheimer's Disease
You're excluded if
- Serious unstable medical illness
- Uncontrolled hypertension
- Abnormal electrocardiogram
- Renal impairment defined as BUN 20 mg/dl and/or creatinine clearance >1.3
- Current drug or alcohol use disorder
- History of seizures without a clear or resolved etiology
- Lifetime history of schizophrenia, schizoaffective disorder, or bipolar 1 or 2 disorder
- Montreal Cognitive Assessment (MoCA) score \<18
- Presence of psychotic symptoms or lifetime psychotic disorder
- Recreational ketamine or phencyclidine use in the last 2 years
- BMI>40
- Serious or imminent suicidal or homicidal risk
- Systolic blood pressure >165 or diastolic blood pressure >95 on infusion day
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-01-29