An evaluation of treatments for sustained clinical response in symptomatic Alzheimer's disease
Information about the drug that will be tested in the study
Name of the drugs
Atomoxetine and metformin
Administration
Oral administration (capsules)
Is the drug already on the market for another medical condition?
Atomoxetine is indicated for the treatment of attention deficit hyperactivity disorder. Metformin is used to lower blood glucose in people with type 2 diabetes.
Will all participants receive the same drug?
Participants will be selected by chance to receive one of the following options:
- An oral administration of metformin (up to 2000 mg/day)
- An oral administration of atomoxetine (up to 100 mg/day
- An oral administration 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 their doctor will know if the person is receiving the investigational drug or the placebo.
Information about participating in the trial
What are the researchers trying to find out?
The purpose of this study is to assess therapeutic benefit by measuring change in cognitive function and activities of daily living over 18 months in people with symptomatic Alzheimer’s disease.
How long will the treatment last?
- 18 months
What your involvement will entail?
- During the study, participants will be asked to complete tests that will assess their cognitive function, memory, activities of daily living and neuropsychiatric and behavioural symptoms
- Undergo brain scans (MRI)
- To complete some laboratory/biological tests (i.e., blood tests) to evaluate the emergent adverse effects (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study..
Further information on the procedures, tests and number of visits can be obtained from the study team.
Who can participate in this study?
Who can participate in the study?
To take part in the study, participants must:
- Be 55 years old and older
- Have a confirmed diagnosis of Alzheimer’s disease or mixed dementia consisting of Alzheimer's disease and vascular dementia
- Have a score above 17.4 points in the MMSE test (a test about your general thinking skills)
- Have confirmatory blood biomarker testing (pTau-217)
- Willing and able to have brain scans (MRI)
- Have normal liver function
- Have a study partner who has a sufficient contact with the participant (at least twice-weekly contact), is willing to participate in study procedures throughout the study duration.
Who cannot participate in the study?
People cannot take part in the study if they have or have experienced:
- Clinical diagnosis of another form of dementia such as Dementia with Lewy Bodies or Frontotemporal Dementia
- Clinical diagnosis of Parkinson’s disease
- Cardiac failure, renal failure, malignancy or significant respiratory comorbidity
- Female participants that are pregnant or breastfeeding
- History of alcohol and/or drug abuse and/or dependence within the 5 years prior to screening visit.
The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.
Information for your doctor
Clinicaltrials.gov identifier
NCT07724132
Study contact information
Link to full text
https://clinicaltrials.gov/study/NCT07724132
The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov) in August 2026.
