← Back to Search

Tau Self-Association Inhibitor

OLX-07010 for Alzheimer's Disease Prevention

Phase 1
Waitlist Available
Research Sponsored by Oligomerix, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part 1:day 1 at 0 hour (pre-dose), 0-4; 4-8; 8-12; and 12-24 hours post-dose. part 2: day 1 and day 7 at 0 hour (pre-dose), 0-4 hours; 4-8 hours; 8-12 hours; 12-24 hours.
Awards & highlights

Study Summary

This trial tests the safety, tolerability, and effects of a tau self-association inhibitor in healthy adults and elderly, with & without food.

Who is the study for?
Healthy adults aged 18-50 and healthy elderly individuals aged 51-75, all of non-childbearing potential, can participate. They must have a stable weight within certain BMI ranges and no significant medical history or current conditions that could affect the study drug's processing in the body.Check my eligibility
What is being tested?
The trial is testing OLX-07010, a new medication aimed at inhibiting tau protein association which is implicated in Alzheimer's disease. It will be given in varying doses to see how safe it is and how it behaves inside the body when taken alone or with food.See study design
What are the potential side effects?
Since this is a first-in-human study for OLX-07010, specific side effects are not yet known but may include typical drug-related reactions such as nausea, headaches, allergic reactions or other unforeseen issues related to the medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part 1:day 1 at 0 hour (pre-dose), 0-4; 4-8; 8-12; and 12-24 hours post-dose. part 2: day 1 and day 7 at 0 hour (pre-dose), 0-4 hours; 4-8 hours; 8-12 hours; 12-24 hours.
This trial's timeline: 3 weeks for screening, Varies for treatment, and part 1:day 1 at 0 hour (pre-dose), 0-4; 4-8; 8-12; and 12-24 hours post-dose. part 2: day 1 and day 7 at 0 hour (pre-dose), 0-4 hours; 4-8 hours; 8-12 hours; 12-24 hours. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events as Measured by Clinical Laboratory Measurements According to Established Clinical Normal Ranges
Incidence of Treatment-Emergent Adverse Events as Measured by ECG
Incidence of Treatment-Emergent Adverse Events as Measured by NCI-CTCAE criteria
+1 more
Secondary outcome measures
Area under the concentration-time curve in plasma (AUC) of OLX-07010 after multiple ascending doses.
Area under the concentration-time curve in plasma (AUC) of OLX-07010 after single ascending doses.
Maximum drug concentration in plasma (Cmax) of OLX-07010 after multiple ascending doses
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ActiveExperimental Treatment1 Intervention
Active OLX-07010 in single ascending and multiple ascending dose cohorts
Group II: PlaceboPlacebo Group1 Intervention
OLX-07010 placebo in single ascending and multiple ascending dose cohorts

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Oligomerix, IncLead Sponsor

Media Library

OLX-07010 (Tau Self-Association Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05696483 — Phase 1
Alzheimer's Disease Research Study Groups: Active, Placebo
Alzheimer's Disease Clinical Trial 2023: OLX-07010 Highlights & Side Effects. Trial Name: NCT05696483 — Phase 1
OLX-07010 (Tau Self-Association Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05696483 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial accept participants who are youthful than 55 years?

"As indicated by the study's eligibility requirements, 18 is the least age for enrolment and 75 years old marks its upper limit."

Answered by AI

Has the FDA issued a formal verification of Active?

"Our team at Power believes that Active holds a safety rating of 1, due to the current phase one status of the trial. This suggests there is limited evidence for both its efficacy and security."

Answered by AI

Who qualifies to join the experiment?

"Meeting the criteria for this research project necessitates that applicants have been diagnosed with Alzheimer's disease and are between 18-75 years old. Currently, 88 individuals may take part in the trial."

Answered by AI

Is this experiment currently recruiting participants?

"According to clinicaltrials.gov, this investigation is not presently enrolling patients for participation. It was initially posted on January 20th of the current year and has seen its most recent update occur on January 23rd. Although persons are unable to join at this time, there are 534 other ongoing studies that require volunteers."

Answered by AI

What outcomes is this clinical trial attempting to achieve?

"According to Oligomerix, Inc., the primary outcome which is observed over a 30-day period after each dose of OLX-07010 includes Treatment Emergent Adverse Events as evaluated by established Clinical Laboratory Measurements. Additionally, secondary outcomes such as Maximum Drug Concentration in plasma (Cmax) and Area under the concentration-time curve in Plasma (AUC), both single and multiple ascending doses will be assessed in this medical trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase 1 Study of OLX-07010 in Healthy Adult and Elderly Participants
2023. "Phase 1 Study of OLX-07010 in Healthy Adult and Elderly Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05696483.
~24 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top