Back to Alzheimers Disease
NCT03418688
NCT03418688
Who may be able to join
Who might be able to join this trial:
- You are between 55 and 80 years old at the time you sign the consent form
- If you are a man who could father children, you must agree to use two forms of birth control or avoid sex from your first dose until 90 days after your last dose
- If you are a woman who could become pregnant, you must not be breastfeeding, must have negative pregnancy tests at certain points, and must agree to use birth control or avoid sex from 10 days before your first dose until 28 days after your last dose
- Any ongoing medications for long-term health conditions must have been at a stable dose for at least 30 days before screening, with no expected changes during the study
- Your body mass index (a measure of body weight relative to height) must be between 19 and 35 at screening
- You are in generally good health based on your medical history, a physical exam, blood tests, and a heart tracing test (ECG)
- You have not smoked or used any tobacco products for at least 6 months before joining and agree not to during the study
- You are able to swallow capsules
- You are fluent in English and can read and understand it
For one specific group in the study (Cohort 4) only:
- You have been diagnosed with probable Alzheimer's disease and score between 14 and 25 on a standard memory and thinking test (MMSE-2)
- A dentist involved in the study has confirmed you have moderate to severe gum disease (periodontitis)
- If relevant, you have a primary caregiver who is willing to help supervise your treatment and monitor your condition throughout the study
- You are able to give written consent yourself, or a legally authorised representative can do so on your behalf, and any caregiver must also provide written consent
Who may not be able to join:
- You have a significant heart rhythm problem, heart failure, or low blood pressure, in the opinion of the study doctor
- You have significant liver disease, either now or in the past, in the opinion of the study doctor
- Your kidneys are not working well enough, based on a specific blood test at screening (confirm with trial site)
- You have had any gum disease treatment in the last 90 days, including antibiotics, scaling, root planing, or any dental surgery
- You have an uncontrolled medical or mental health condition, uncontrolled seizures, or a history of a major stroke
- You have had a serious infection within the last 30 days before screening that needed more than one week of antibiotic treatment
- You have a history or current signs of mental or emotional difficulties that would affect your ability to consent or follow study requirements
- You have had a significant allergic reaction to any medication, in the opinion of the study doctor
- You have had problems with alcohol or drug misuse or dependence within the past 12 months
- You test positive for alcohol at screening or on the day before the study starts
- You test positive for any prohibited drugs in a urine test
- You test positive for HIV, hepatitis B, or hepatitis C in a blood test at screening
- The study doctor believes for any reason that joining the study would not be safe or suitable for you
- Your screening blood tests, ECG, or brain MRI show results that the study doctor considers a concern
- You are currently taking a medication that cannot safely be stopped or swapped out during the study
- You have taken part in another drug research study using a small-molecule drug within the last 30 days, or a biological drug within the last 60 days
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Trial details
Status
Completed
Phase
Phase 1
Sponsor
Cortexyme Inc.
Registry
clinicaltrials_gov
Start date
6 March 2018
Est. completion
15 October 2018
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
AUC; Cmax; Tmax
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.