The purpose of this study is:To investigate how glutamate is processed in the brain using magnetic resonance, a non-invasive technique used to see images of your brain. Glutamate is a chemical that sends signals between nerve cells in the brain.
ID
Source
Brief title
Condition
- Other condition
- Dementia and amnestic conditions
Synonym
Health condition
Depressed mood disorders and disturbances, Schizophrenia and other psychotic disorders
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- 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
<=25%.
Secondary outcome
- 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
Background summary
This study will investigate a new, non-invasive technique to measure changes in
glutamate. Glutamate plays an important role in learning and memory and may
play a role in many disorders such as Alzheimer*s disease, schizophrenia,
depression, substance use disorders, seizures, and other brain disorders.
Study objective
The purpose of this study is:
To investigate how glutamate is processed in the brain using magnetic
resonance, a non-invasive technique used to see images of your brain. Glutamate
is a chemical that sends signals between nerve cells in the brain.
Study design
If The volunteer does participate, this will last a total of 6.5 to 8.5 weeks
(from screening until the follow-up visit) for the volunteer, depending on
which part of the study the volunteer participate in.
The volunteer will be treated with the study intervention 1 or 2 times,
depending on the part the volunteer participates in. The study will consist of
3 parts. The volunteer will participate in either Part 1, Part 2, Part 3, or
(if the volunteer choose) both Parts 1 and 2.
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 sugar found in corn (subjects
in Part 1), or 13C glucose (subjects in Parts 2 or 3).
Intervention
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 sugar found in corn (subjects
in Part 1), or 13C glucose (subjects in Parts 2 or 3).
Study burden and risks
The study intervention may cause side effects/adverse effects.
Disadvantages of participating in the study may be:
- Possible side effects of the study intervention;
- Possible adverse effects or discomforts of the evaluations in the study;
- Administration of study intervention according to strict procedures;
- Disadvantages for your partner/those living with you;
- Participation in the study may lead to incidental findings about your health.
You may not wish to know this.
- Covid test
P.O. Box 100 Whitehouse Station
New Jersey 08889-0100
US
P.O. Box 100 Whitehouse Station
New Jersey 08889-0100
US
Listed location countries
Age
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 <=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.
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75257.056.20 |