Study on the thresholds for action to improve cognition

JRCT ID: jRCTs031240602

Registered date:14/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: healthy
• Date of first enrollment: 16/01/2025
• Target sample size: 12
• Study type: Interventional
• Intervention(s): After taking (1) pseudoephedrine or placebo, or (2) modafinil or placebo, central nervous system effects will be evaluated by a PET scan using [18F] FE-PE2I, cognitive tasks and fMRI.

Outcome(s)

• Primary Outcome: DAT binding capacity in striatum, nucleus accumbens, thalamus and substantia nigra by [18F] FE-PE2I

Secondary Outcome

1. Signal values of fMRI (BOLD signal).
2. Correct response rate and reaction time of cognitive tasks performed by subjects during fMRI imaging.
3. Concentration of pseudoephedrine and modafinil in plasma and urine, and caffeine in urine during PET and fMRI examinations.
4. Assessment of cognitive function by cognitive function test.
5. Safety evaluation.
Percentage of adverse events.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 40age old
• Gender: Male

Include criteria

1) Subjects who are 20 years old or older and younger than 40 years old when obtaining consents.
2) Subjects with no history of psychiatric and/or neurological disorders.
3) Subjects with normal BMI (18.5 - 25).
4) Subjects without the history of smoking. (Subjects without the history of smoking is defined as "subjects who has never smoked more than 100 cigarettes in total and for more than 6 months, and who has not smoked in the past month.")
5) Subjects who have the ability to provide informed consent and adhere to the protocol.

Exclude criteria

1) Subjects who fall under contraindications to the administration of pseudoephedrine (pseudoephedrine group).
(a) Subjects with a history of hypersensitivity to fexofenadine hydrochloride/pseudoephedrine hydrochloride components or compounds similar in chemical structure to pseudoephedrine hydrochloride (preparations containing ephedrine hydrochloride or methylephedrine hydrochloride).
(b) Subjects with severe hypertension (systolic blood pressure of 180 mmHg or higher or diastolic blood pressure of 110 mmHg or higher).
(c) Subjects with severe coronary artery disease (e.g., angina pectoris, myocardial infarction, etc.).
(d) Subjects with angle-closure glaucoma.
(e) Subjects with urinary retention.
(f) Subjects with a history of insomnia, dizziness, weakness, tremor, arrhythmia, etc. caused by sympathomimetic drugs.
2) Subjects with contraindications to administration of modafinil (modafinil group).
(a) Subjects with serious arrhythmia (e.g. ventricular fibrillation, sustained ventricular tachycardia, etc.).
(b) Subjects with a history of hypersensitivity to any ingredient of Modafinil.
3) Subjects with a history of gastrointestinal symptoms upon lactose ingestion.
4) Subjects who are scheduled to receive drug therapy within one week prior to the first or second dose.
5) Subject who wear a device (cardiac pacemaker, cerebral aneurysm clip, etc.) that is affected by the high magnetic field of the MRI machine, or has a machine or metal in his/her body.
6) Subjects who plan to consume caffeine from 2 days prior to the first or second administration of medication until the end of the test, or alcohol from 1 day prior to the first or second administration of medication until the end of the test.
7) Subjects who have been exposed to more than 15 mSv (millisieverts) per year due to radiation exposure from work or radiation therapy (15 mSv is equivalent to 3-4 stomach X-rays).
8) Subjects who wish to participate in a competition in which doping tests are conducted.
9) Subjecs who are scheduled to receive a contrast agent or radiopharmaceutical between two days prior to the first or second administration of the medication and the day following the administration of the medication.
10) Subjects who do not agree to be notified of the results of any treatment deemed necessary by the investigator based on the test results obtained in this study.
11) Any other subjects who is judged by the investigator to be inappropriate to participate in this study.

Related Information

• Primary Sponsor: Tateno Amane
• Source(s) of Monetary Support: Japan Anti-Doping Agency