Study Information

Name of the study

A study to evaluate the safety, tolerability and immunogenicity of Tau targeted vaccines in participants with early Alzheimer's disease

Study sponsor

AC Immune SA

Disease

Early Alzheimer's disease

Phase

Phase Ib/IIa

Information about the drug that will be tested in the study

Name of drug

ACI-35.030

Administration

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

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

No

Will all participants receive the same drug?

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

• A subcutaneous injection of ACI-35.030 (low dose)
• A subcutaneous injection of ACI-35.030 (medium dose)
• A subcutaneous injection of ACI-35.030 (high dose)
• A subcutaneous injection of ACI-35.030 JACI-35.054
• A subcutaneous injection of placebo (inactive substance identical in appearance to the drug being tested).

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 the study is to evaluate the safety, tolerability and immunogenicity of different doses, regimens and combinations of Tau targeted vaccines in participants with early Alzheimer's disease.

How long will the treatment last? 

Around 1 year.

What will your involvement entail?

• During the study, participants will have to undergo brain scan (MRI) to see if they have amyloid pathology in their brain
• Complete some laboratory tests (i.e. blood pressure, heart rate) to evaluate the emergent adverse events (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study)
• Complete a test that will assess memory, orientation, judgment and problem solving, personal care and community affairs (this is a test called CDR)
• Participants will also need to complete some other tests to evaluate their cognition, behaviour and function (e.g. RBANS, NPI).

Further information on the procedures 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 50 to 75 years old
• Have a diagnosis of mild cognitive impairment due to Alzheimer’s disease or mild to Alzheimer’s disease according to the National Institute on Aging/Alzheimer's Association core clinical criteria
• Have a score of 0.5 to 1 in the Clinical Dementia Rating-Global Score (CDR) and a score of 22 or above in the MMSE test (a test about your memory). This would suggest that the person has an impairment in their memory that is at a very 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 3 weeks prior to the baseline visit
• Be post-menopausal for at least one year or permanently sterilized for female participants
• 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?

Exclusion criteria include:

• Participation in other clinical studies involving anti-amyloid therapies, unless it can be confirmed that the participant only received placebo
• Participation in previous clinical trials for neurological disorders using any passive immunization within the past 12 months prior to screening or using small molecule drug within the past 3 months prior to screening
• A disease that may interfere with the safety, tolerability and/or study assessments, or put the participant at special risk (e.g. auto-immune disease, inflammatory neurological disorders)
• Drug or alcohol abuse or dependence
• History of a stroke, transient ischemic attack or seizures
• History of cancer within the past 5 years
• A pregnancy or breast-feeding for female participants
• Positive HIV test or Active hepatitis B and/or C.

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

Where and when will the study be conducted?

European countries involved in the trial (active)

• Finland
• Netherlands

European country that will be involved in the trial (planned)

• UK

Estimated start date of recruitment

June 2020

Information for your doctor

EudraCT Number

2018-004573-27

Clinicaltrials.gov identifier

NCT04445831  

Study contact information

clinicaltrials@acimmune.com

Link to full text

https://clinicaltrials.gov/ct2/show/NCT04445831

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on February 2021.

The pharmaceutical company running this trial has not reviewed this document.

This document has been reviewed by a member of the European Working Group of People with Dementia.