Health TrialsbyHealthPanel

A Study to Assess THN391 in Subjects With Alzheimer's Disease

ConditionAlzheimer Disease, Early Onset
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age65-85
SponsorTherini Bio, Inc.

About this trial

This is a Phase 1b study to evaluate different doses of the drug and see whether a drug is safe and how it behaves in the body.

THN391 has already been assessed in healthy people without Alzheimer's disease. This is the first study of THN391 in patients with Early Alzheimer's disease. Later studies will evaluate THN391 to see if it is effective for the treatment of Alzheimer's disease.

In this study, THN391 will be compared with a placebo (a look-alike substance that contains no drug). The study duration is approximately 6 months in which the participants will visit the clinic approximately 13 times and have 2 telephone calls with the site.

Patients who fulfill all criteria to participate in the study, will receive 3 times a monthly dose of THN391 or placebo in the clinic.

Assessments that will be done at several timepoints during the study will be blood collection, physical examinations and neurological examinations, 4x an MRI-scan of the head, 2x a spinal tap and some testing of the memory and thinking skills.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity

65 to 85 years of age (inclusive at the time of informed consent).

Diagnosis of Early Alzheimer's Disease (AD)

Diagnosis of cerebral Small Vessel Disease (cSVD), and having at least one of the following vascular risk factors: hypertension, Type 2 diabetes mellitus, or hyperlipidemia

Disqualifiers

Diagnosis of moderate or severe dementia

Any other medical condition except for early AD (e.g. any clinically significant neurological, psychiatric or large vessel disease) that could affect interpretation of study assessments

Use of anticoagulant, except for either clopidogrel or low dose aspirin, unless taken simultaneously

Trial design

Design model

Sequential

Treatments tested in this trial

  • THN391

    Drug

    THN391, IV infusion, 3\*Q4W (every 4 weeks)

  • Placebo

    Drug

    Placebo for comparison with THN391, IV infusion, 3\*Q4W

Treatment groups

15 Participants
are divided into 3 treatment groups
Group A: Cohort 1Experimental treatment 2 interventions
Group B: Cohort 2Experimental treatment 2 interventions
Group C: Cohort 3Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

To assess the safety and tolerability of multiple doses of THN391 in Early AD subjects via AEs

Incidence of Adverse Events (AEs)

Time frame
From enrollment to the end of the follow-up period at week 24
2

To assess the safety and tolerability of multiple doses of THN391 in Early AD subjects via SAEs

Incidence of Serious Adverse Events (SAEs)

Time frame
From enrollment to the end of the follow-up period at week 24
3

To assess the pharmacokinetics (PK) of multiple doses of THN391 in Early AD subjects

Serum and CSF concentration of THN391 using validated analytical method at specified timepoints The PK parameters will be determined or calculated using non-compartmental analysis from the serum concentration time data for THN391. A complete list of PK parameters will be provided in the statistical analysis plan (SAP).

Time frame
From the first dosing to the end of the follow-up period at week 24
4

To assess the maximum plasma concentration (Cmax) for THN391 in Early AD subjects

Evaluate Cmax for serum and CSF concentration of THN391 at specified time points

Time frame
From the first dosing to the end of the follow-up period at week 24

Secondary outcomes

1

To assess the immunogenicity of multiple doses of THN391 in Early AD subjects

Occurrence of antidrug antibodies (ADA) to THN391

Time frame
From the first dosing to the end of the follow-up period at week 24
2

To assess the effects of THN391 on coagulation in Early AD subjects via aPTT

Changes in activated partial thromboplastin time (aPTT)

Time frame
From enrollment to the end of the follow-up period at week 24
3

To assess the effects of THN391 on coagulation in Early AD subjects via INR

Changes in international normalized ratio (INR)

Time frame
From enrollment to the end of the follow-up period at week 24
4

To assess the effects of THN391 on coagulation in Early AD subjects via PT

Changes in prothrombin time (PT)

Time frame
From enrollment to the end of the follow-up period at week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Therini Bio, Inc.

Lead sponsor

Source ClinicalTrials.gov
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