Alzheimers Disease thinking and behavior type of dementia that affects memory
Conditions
Interventions
Part 1:
For tyramine, the scheduled dosages are as follows:
- All treatment groups will receive Tyramine up to 100 mg to 600 mg once daily
as oral capsules from Days 1 to 6.
- All treatment groups w
Sponsors
TauRx Therapeutics Ltd.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Signature of an Independent Ethics Committee approved written informed consent prior to any clinical study-related procedures. 2. Male or female subjects 2.1. Aged 18 to 60 years, inclusive (Tyramine Challenge Parts 1 and 2); 2.1.1. The goal will be to enroll approximately 12 or more subjects aged >=50 years in each part. 2.2. Aged >=50 years (PK Substudy). 3. Weighing between 50 and 110 kg, inclusive such that the body mass index (BMI) is 18.5 to 32 kg/m2, inclusive. 4. In good health in the opinion of the PI as determined by: 4.1. Medical history; 4.2. Physical examination; 4.3. Vital signs assessment; 4.4. 12-lead electrocardiogram (ECG); and 4.5. Clinical laboratory evaluations. 5. If female, must meet one of the following: 5.1. Be permanently sterile, defined as at least 6 months following hysterectomy, bilateral salpingectomy, or bilateral oophorectomy. 5.2. Have undergone bilateral tubal occlusion / ligation at least 6 months prior to screening. 5.3. Be postmenopausal, defined as at least 12 months post cessation of menses (without an alternative medical cause); postmenopausal status will be confirmed with a screening serum follicle stimulating hormone (FSH) level greater than 33.4 mIU/mL. 5.4. Using adequate contraception and agree to do so throughout study participation and for 90 days after the last dose of study drug; the following are considered effective forms of birth control: 5.4.1. Hormonal contraceptives started at least 90 days prior to study drug administration; 5.4.2. Intra-uterine contraceptive device (hormonal or non-hormonal) placed at least 4 weeks prior to study drug administration; 5.4.3. Male condom; 5.4.4. Sterile male partner (vasectomized for at least 6 months); and 5.4.5. True abstinence (when this is in line with the preferred and usual lifestyle of the subject). 6. If female, including those who have underwent hysterectomy, must agree to not donate ova starting from Day -1 and throughout the clinical study period, and for at least 28 days after the final study drug administration. 7. If male and sexually active with a female partner of childbearing potential (childbearing potential females are defined as women who are neither postmenopausal nor surgically sterile), must be willing to use one of the following acceptable contraceptive methods from the first study drug administration until at least 90 days after the last study drug administration: 7.1. Simultaneous use of a male condom and, for the female partner, hormonal contraceptives used since at least 4 weeks or intra-uterine contraceptive device placed since at least 4 weeks; 7.2. Simultaneous use of a male condom and, for the female partner, a diaphragm or cervical cap. 8. If male, must agree to not donate sperm from Day -1 until 90 days after the final study drug administration.
Exclusion criteria
Exclusion criteria: 1. If female, pregnant or lactating. 2. History of allergy/sensitivity to the following: 2.1. Phenelzine, selegiline, or other drugs of a similar class (Tyramine Challenge Parts 1 and 2 only). 2.2. Methylthioninium (methylene blue) or similar organic dyes, as determined by the PI. 2.3. Any of the excipients used in LMTM (which include mannitol, cellulose, crospovidone, and magnesium stearate). 3. Clinically significant history of allergic conditions (including severe hypersensitivity drug reactions, asthma, eczema or anaphylactic reactions, but excluding untreated, asymptomatic seasonal allergies at the time of dosing), as judged by the PI. 4. For Tyramine Challenge Parts 1 and 2 only, subject is unable to swallow the capsule sizes used in this study. 5. Febrile illness or symptomatic viral, bacterial (including upper respiratory infection), or fungal (noncutaneous) infection within 1 week prior to admission to the clinical unit. Further criteria apply, see protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether LMTM inhibits MAO as evidenced by a reduction in the dose of tyramine required to produce a 30-mmHg increase in systolic blood pressure (SBP), compared with placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To characterize the multiple-dose pharmacokinetics (PK) of LMTM. - To assess the safety and tolerability of LMTM. | — |
Countries
Netherlands
Outcome results
None listed