ASURE

Alzheimer Study Using oRal Edaravone

Conditions

Sponsor

Treeway B.V.

Clinical Trial

Status

Drug

TW001 (also called Edaravone)

Countries

Croatia, Netherlands

The drug will be administered in a fasted state via an oral dose once daily.

Yes - antioxidant drug marketed in the US and Japan to treat amyotrophic lateral sclerosis.

Participants will be selected by chance to receive one of the following options:

An oral dose of TW001 (100mg)
An oral dose of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect).

Neither the participant nor his/her doctor will know if the person is receiving the investigational drug or the placebo.

The purpose of the study is to evaluate the safety, pharmacodynamics and pharmacokinetics of TW001 in people with mild Alzheimer’s disease.

The treatment lasts 90 days

The total duration of the clinical trial will be approximately four months per participant.

During the study, participants will be asked to complete some laboratory and biological tests such as blood and urines tests
Participants will be asked to complete tests that will assess cognition, memory and behaviour (i.e. tests like CDR-SB, MMSE)
Participants will also undergo lumbar puncture (CSF).

Further information on the procedures, tests and number of visits can be obtained from the study team.

To take part in the study, participants must:

Be between 55 and 80 years old
Have a body mass index between 18.5 to 30.0 kg/m2
Have a diagnosis of early Alzheimer’s disease according to the National Institute on Aging/Alzheimer's Association (NIA-AA) core clinical criteria
Have a score of 20 or above in the MMSE test (a test about memory). This would suggest that the person has an impairment in their memory that is at a mild stage
Have gradual and progressive change in memory function over more than 6 months
Have evidence of abnormal accumulation of amyloid and Tau in the brain (as per results of CSF, PET scan)
Have a study partner who has a sufficient contact with the participant, is willing to participate in study procedures throughout the study duration
If the person is taking medication, supplements or vitamins that may have an influence on the study, the dosing regimen must have been stable for a least one month and the person must be willing to remain on the same treatment and dose for the duration of the trial
Use highly effective contraception
Women of non-childbearing potential (surgically sterilized or post-menopausal).

People cannot take part in the study if they have or have experienced:

A disease or medical condition that may interfere with the study assessments and will make the participant unsuitable for participation in or completion of the trial procedures (i.e. delirium, psychosis, psychiatric disorder, stroke, uncontrolled or significant cardiac disease, cancer)
Any diagnosis of relevant neurological disorder other than Alzheimer's disease such as vascular dementia, frontotemporal dementia, Parkinson's disease, dementia with Lewy Bodies, Huntington's disease
History of stroke, renal impairments, hepatic disease
History of seizures or epilepsy within the past 5 years
Positive HIV test or Active hepatitis B and/or C
Any alcohol or drug abuse or dependence
Treatment with any investigational drug within the past 30 days.

The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.