Pilot clinical study of CT1812 in mild to moderate Alzheimer's disease using EEG
Information about the drug that will be tested in the study
Administration
A capsule taken orally
Is the drug already on the market for another medical condition?
No
Will all participants receive the same drug?
Participants will be selected at random to either receive one of the following options:
- A capsule of CT1812 (300mg) during the period 1 followed by a capsule of placebo during period 2, or
- A capsule of placebo during the period 1 followed by a capsule of CT1812 (300mg) during period 2
Placebo is 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.
Information about participating in the trial
What are the researchers trying to find out?
The purpose of the study is to evaluate the effect of CT1812 treatment on synaptic activity in people with mild to moderate Alzheimer's disease.
How long will the treatment last?
Participants will receive CT1812 or placebo during a 2-period crossover of 29 days.
What your involvement will entail?
- During the study, participants will be asked to do some blood tests to analyse the plasma concentration
- Participants will also be asked to undertake brain scans and lumbar punctures (CSF) to see changes in biomarkers in the brain.
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 between 50 and 85 years old
- Have a diagnosis of mild to moderate Alzheimer's disease according to the 2018 NIA-AA criteria
- Have a history of decline in cognitive function reported by a doctor for at least six months
- Have a score between 18 and 26 in the MMSE test questionnaire test (a test about your memory). This would suggest that the person has an impairment in their memory that is at a mild to moderate stage
- Have evidence of abnormal accumulation of amyloid in the brain (determined through neuroimaging and CSF)
- Have a study partner who has a sufficient contact with the participant, 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:
- Participants living in a continuous care nursing facility
- Contraindication to brain scans (PET, MRI)
- Other degenerative dementia such as dementia with Lewy bodies, Fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, Parkinson's disease, amyotrophic lateral sclerosis
- A disease or conditions that may interfere with the safety, tolerability and/or study assessments, or put the participant at special risk (e.g. psychiatric symptoms, auto-immune disease, inflammatory neurological disorders
- Participants must not have cancer within the last 3 years
- Participants must not have history of HIV, Hepatitis B or C
- Drug or alcohol abuse.
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
NCT04735536
Study contact information
Jiney Asthappan
Link to full text
https://clinicaltrials.gov/ct2/show/NCT04735536
The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on March 2022.
