ABATE

A study to assess the effects of ACI-24.060 in Alzheimer's disease and in Down Syndrome

Conditions

Prodromal/Mild Cognitive Impairment due to Alzheimer’s disease

Sponsor

AC Immune SA

Phase

Phase II

Status

Currently recruiting

Drug

ACI-24.060

Countries

United Kingdom

Information about the drug that will be tested in the study

Administration

The vaccine will be administered via a subcutaneous injection (an injection under the skin).

Is the drug already on the market for another medical condition?

Will all participants receive the same drug?

Participants will be selected at random to either receive one of the following options:

A subcutaneous injection of ACI-24.060
A subcutaneous injection 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.

Information about participating in the trial

What are the researchers trying to find out?

The purpose of the study is to evaluate the safety, tolerability and efficacy of ACI-24.060 in people with prodromal Alzheimer's disease and in people with Down Syndrome.

How long will the treatment last?

48 weeks for people with prodromal Alzheimer's disease

What your involvement will entail?

During the study, participants will be asked to complete a test that will assess their suicidal ideation behaviour (this is a test called C-SSRS)
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
To complete other tests that will assess their cognition and memory (i.e. tests like CDR, RBANS, ADAS-Cog, mCRT, CANTAB-PAL)
Participants will be asked to undertake brain scans (PET, MRI).

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 75 years old
Have evidence of abnormal accumulation of amyloid in their brain (PET scan)
Have a score of 0.5 in the Clinical Dementia Rating-Global Score (CDR). This would suggest that the person has an impairment in its memory that is at a mild stage
If the person is taking approved symptomatic medication for dementia (i.e. donepezil, rivastigmine, galantamine or memantine) the dosing regimen must have been stable for at least 2 months prior to the baseline visit.

Who cannot participate in the study?

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

A disease or condition that may interfere with the safety, tolerability and/or study assessments (e.g. moderate and/or severe untreated obstructive sleep apnea, clinically significant reduction in serum B12 or folate levels, clinically significant abnormalities of thyroid function, stroke, or other cerebrovascular conditions
Any alcohol or drug abuse
Concomitant or past history psychiatric or neurologic disorder other than those considered to be related to Alzheimer’s disease (e.g. head injury with loss of consciousness, symptomatic stroke, Parkinson's disease, severe carotid occlusive disease, transient ischemic attacks hemorrhagic and/or non-hemorrhagic stroke)
Significant risk of suicide
Positive HIV test or Active hepatitis B and/or C
Ongoing participation in other clinical studies with any approved anti-amyloid passive immunotherapy for Alzheimer's disease
Previous treatment with ACI-24 or any immunotherapy against Alzheimer’s disease
Use of symptomatic treatments of Alzheimer’s disease (e.g. acetylcholinesterase inhibitors and memantine) if not on stable dose for at least 2 months before screening.

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