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Alzheimer DiseasePhase 2NCT05323812

ASURE: Alzheimer Study Using oRal Edaravone

A Phase 2 study testing TW001 in people with Alzheimer Disease, run by Treeway B.V. at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multi-center, Phase IIa, randomized, double-blind, placebo-controlled study in patients with Alzheimer's Disease (AD). Read more about this study

Who is it for?
Ages 55 to 80 years
Conditions the study is for
Alzheimer Disease
What is being tested?
TW001
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
61 participants
Where
6 sitesin 2 countries
Study dates
1 Mar 2023to 30 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 55-80 years (both inclusive), male or female.
  • Body mass index between 18.5 to 33.0 kg/m2 (both inclusive).
  • Should meet the criteria for early clinical stage Alzheimer's Disease (AD) according to the National Institute on Aging and Alzheimer's Association (NIA-AA) criteria research framework:
  • Gradual and progressive change in memory function reported by patient or informant over more than 6 months,
  • Clinical syndrome of Mild Cognitive Impairment (MCI) due to AD or mild AD dementia,
  • An Mini-Mental State Exam (MMSE) score ≥ 20 at screening,
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  • Biomarker classification according to the Amyloid/Tau/Neurodegeneration (ATN) as A+T+N+ or A+T+N- based upon:
  • Cerebrospinal fluid (CSF) profile consistent with AD (an Aβ42 concentration of <1000 pg/mL AND phosphorylated tau (p-tau) >19 pg/mL, or a ratio of p-tau/Aβ42 of ≥0.020) taken during the screening period prior to the day of the first dose of study medication, or
  • Documented evidence of a CSF profile consistent with AD obtained with the previous 12 months, or
  • Documented amyloid positron emission tomography (PET) scan evidence acquired within the previous 12 months.
  • A reliable and competent trial partner/caregiver who can assist and witness dosing and is willing to accompany the patient to all visits. The trial partner/caregiver should understand the nature of the trial and adhere to trial requirements (e.g., visit schedules, evaluations) and confirm this by co-signing the informed consent of the patient or signing of a separate informed consent of the partner/caregiver according to the local requirements.
  • If a patient is taking medication, supplements or vitamins that may have an influence on oxidative stress, cognition and/or EEG, the dose must be stable at screening for at least one month, and the patient must be willing to remain on the same treatment and dose for the duration of the trial.
  • A male patient abstains from sexual intercourse, or is vasectomized (> 6 months), or will use a condom with spermicide during sexual intercourse during the trial and for three months after participation in the trial and will abstain from sperm donation during the trial and for three months after participation in the trial.
  • A female patient should not be of reproductive potential:
  • A female patient who is not of reproductive potential is defined as one who:
  • Has reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone [FSH] levels in the postmenopausal range as determined by the local laboratory, or 12 months of spontaneous amenorrhea);
  • Is 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy; or
  • Has undergone bilateral tubal ligation. Spontaneous amenorrhea does not include cases for which there is an underlying disease that causes amenorrhea (e.g., anorexia nervosa).
  • Capable of providing informed consent and complying with trial procedures.

Who cannot join

  • A known history of stroke that is clinically important in the investigator's opinion.
  • Evidence of a clinically relevant neurological disorder other than AD at screening, including but not limited to: vascular dementia, Parkinson's disease, frontotemporal dementia, Huntington's disease, amyotrophic lateral sclerosis, multiple sclerosis, progressive supranuclear palsy, dementia with Lewy bodies, other types of dementia, neurosyphilis or head trauma with loss of consciousness that led to persistent cognitive deficits.
  • A history of seizures or epilepsy within the last 5 years before screening.
  • Evidence of a clinically relevant or unstable psychiatric disorder, based on the 5th edition after text revision of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5TM) criteria, including schizophrenia or other psychotic disorder, bipolar disorder, major depression, or delirium. Major depression in remission is not exclusionary.
  • Renal impairment as indicated by a creatinine clearance of less than 50 mL/min as calculated by the Cockcroft Gault equation.
  • Patient has a history of any of the following conditions:
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  • Clinically significant hepatic disease,
  • AST or ALT levels of ≥ 2 times upper limit of normal (ULN),
  • Biliary tract disease,
  • Patient has a positive screening test for HIV, hepatitis B or C.
  • Presence of any of the following clinical conditions:
  • Unstable cardiac, pulmonary, endocrine, hematologic or active infectious disease,
  • Unstable psychiatric illness defined as psychosis, untreated major depression within 90 days of the screening visit,
  • A history of cancer within the past 3 years prior to screening other than treated squamous cell carcinoma, basal cell carcinoma and melanoma in situ, or in-situ prostate cancer or in-situ breast cancer which have been fully removed and are considered cured
  • History or signs/symptoms of lumbar spine/disc disease including but not limited to scoliosis, herniation, or any other contraindication to lumbar puncture.
  • History of known sensitivity or intolerability to edaravone, related substances of edaravone, or to any of the excipients.
  • Current substance or alcohol dependence.
  • Exposure to any investigational drug within 30 days of the screening visit.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Netherlands4 sites

  • Brain Research Center Den Bosch

    's-Hertogenbosch, 5223 LA

  • Brain Research Center Amsterdam

    Amsterdam, 1081 GN

  • ETZ Elisabeth ziekenhuis

    Tilburg, 5022 GC

  • Brain Research Center Zwolle

    Zwolle, 8025 AZ

Other trials in Netherlands

Croatia2 sites

  • University Hospital Centre Osijek

    Osijek, 31000

  • University Hospital Centre Zagreb

    Zagreb, 10000

Other trials in Croatia

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of TW001 in Alzheimer Patients

This is a multi-center, Phase IIa, randomized, double-blind, placebo-controlled study in patients with Alzheimer's Disease (AD).

Read the detailed description

This is an exploratory, double-blind, randomized, placebo-controlled phase IIa proof of concept study to evaluate the safety, pharmacodynamics and pharmacokinetics of TW001 in patients with mild AD. Patients will be randomized 1:1 to TW001 and placebo. Treatments will be given in a fasted state once daily for 90 days. The total duration of the clinical trial will be approximately 4 months per patient.

Being tested
TW001, Placebo
Keywords
Alzheimer's Disease, Oxidative stress biomarkers, Free radical scavenger, Edaravone
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TW001Drug

    Also called Edaravone

    daily dose of 100 mg TW001/placebo

  • PlaceboDrug

    daily dose of 100 mg TW001/placebo

Study groups in NCT05323812
Study groupRoleWhat they receive
TW001ExperimentalNot described
Receives: Drug: TW001
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nature, frequency and severity of adverse events

    Safety and tolerability as measured by nature, frequency and severity of adverse events and serious adverse events

    Measured: Through study completion, up to 4 months

  2. Plasma oxidative stress biomarkers

    Changes from baseline in: 8-OHdG/8-OHG and Uric acid in plasma

    Measured: Through study completion, up to 4 months

  3. Cerebrospinal Fluid (CSF) oxidative stress biomarkers

    Changes from baseline in: 8-OHdG/8-OHG in CSF

    Measured: Through study completion, up to 4 months

Secondary outcomes (4)

  1. Plasma concentration of TW001

    Measured: Through study completion, up to 4 months

  2. Area under the concentration versus time curve (AUC) of TW001

    Measured: Through study completion, up to 4 months

  3. Maximum plasma concentration (Cmax) of TW001

    Measured: Through study completion, up to 4 months

  4. Time to reach maximum plasma concentration (tmax) of TW001

    Measured: Through study completion, up to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2022
  2. Study start1 Mar 2023
  3. Primary completion30 Dec 2024
  4. Study completion30 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05323812
Sponsor's protocol ID
TW001-AD-C2.01
Other IDs
2021-003164-27
Status last verified
Sep 2024
First submitted
16 Mar 2022
Last updated
23 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TW001 in people with Alzheimer Disease, run by Treeway B.V. at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Netherlands, Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nature, frequency and severity of adverse events (time frame: Through study completion, up to 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05323812.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.

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ASURE: Alzheimer Study Using oRal Edaravone | AzTrials