Depressed mood disorders and disturbances, Schizophrenia and other psychotic disorders Alzheimers disease schizophrenia
Conditions
Interventions
The volunteer will receive an infusion into a vein in his arm, hand, leg, or
foot, for up to 2 hours of a sugar, which is the study intervention. The
volunteer will either receive dextrose, a simple
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Is in good health based on medical history, physical examination, VS measurements and ECGs performed prior to randomization (referring to Appendix 9 of the protocol). 2. Is in good health based on laboratory safety tests obtained at the screening visit (referring to Appendix 2 and 10 of the protocol). 3. Have a fasting blood glucose
Exclusion criteria
Exclusion criteria: 1. Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases. • Candidates with Type 1 or 2 diabetes are specifically excluded. Participants with a remote history of uncomplicated medical events (eg, uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma) may be enrolled in the study at the discretion of the investigator. 2. Is mentally or legally incapacitated, has significant emotional problems at the time of pre-study (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years. Participants who have had situational depression may be enrolled in the study at the discretion of the investigator. 3. Has a history of cancer (malignancy). Exceptions include adequately treated non-melanomatous skin carcinoma or other malignancies which have been successfully treated with appropriate follow up and are therefore unlikely to recur for the duration of the study, in the opinion of the investigator and with agreement of the Sponsor (eg, malignancies which have been successfully treated >=10 years prior to the pre-study [screening] visit). 4. Has a history of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (ie, systemic allergic reaction) to prescription or non-prescription drugs or food. 5. Is positive for hepatitis B surface antigen, hepatitis C antibodies or HIV. 17. Parts 2 and 3 only: Has implanted metal objects (including pacemakers, neurostimulators, vascular clips, cochlear or other auditory implants, hydrocephalus/insulin/medicine pumps, vascular stents, etc), works with metal (ie, welder), or has any other exclusion criteria that prevents participation in an MRI scan. For complete overview see the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Part 1 - Objective: Determine the infusion parameters required to stably maintain plasma glucose concentrations of ~7-10 mM with an IV infusion of dextrose. - Part 2- Objective: Evaluate the parameters (infusate concentration, rate and duration of infusion) for maintaining plasma glucose concentrations of ~7-10 mM over a typical scan period using a [U-13C] glucose infusion. - Parts 2, 3 - Evaluation: Determine the fractional enrichment of 13C-glutamate, glutamine in the brain that can be achieved using an IV [U-13C] glucose infusion that maintains total plasma glucose at ~7-10 mM. - Part 3-Objective: Assess the intra-subject test/retest variability around measures of the maximal fractional enrichment of 13C-labeled Glu and Gln levels in the prefrontal cortex of healthy adults using selPOCE MRS. - Hypothesis: The mean difference in the maximal fractional enrichment of 13C-labeled Glu and Gln determined on 2 scan dates >=2 weeks apart under baseline conditions (without pharmacologic intervention) in healthy adults is | — |
Secondary
| Measure | Time frame |
|---|---|
| - All parts: Monitor the safety and tolerability of glucose infusions - Part 3 - Objective: Determine Vcycle and VTCA in the prefrontal cortex of healthy adults using selective, proton observed, carbon edited magnetic resonance spectroscopy | — |
Countries
Netherlands
Outcome results
None listed