An Investigation of the Test-Retest Variability of Measures of the Fractional Enrichment of Glutamate/Glutamine in Healthy Adults Measured Using Selective Proton Observed, Carbon Edited (selPOCE) MRS
- Conditions
- 10012272Depressed mood disorders and disturbances, Schizophrenia and other psychotic disordersAlzheimers diseaseschizophrenia
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 28
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 <=110 mg/dL and a Hb1Ac <= 6.1%.
4. Have a BMI <=30 kg/m2, inclusive.
5. Is male, from 18 years to 50 years of age inclusive, at the time of signing
the informed consent.
6. The participant provides written informed consent/assent for the study,
including for future biomedical research.
7. Has acceptable venous access.
8. Is willing to comply with the study restrictions.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method