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APOLLOE4

A Phase 3, multicenter, randomised, double-blind, placebo-controlled study of the efficacy, safety and biomarker effects of ALZ-801 in subjects with early Alzheimer's disease and APOE4/4 genotype

Sponsor
Alzheon Inc.
Phase
Drug
ALZ-801

Information about the drug that will be tested in the study

Administration

Oral tablet in the morning and one tablet in the evening

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:

  • An oral tablet of ALZ-801 (265mg) twice daily
  • An oral capsule of placebo (inactive substance identical in appearance to the drug being tested) twice daily.

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 and efficacy of ALZ-801 in people with early Alzheimer's disease with the APOE4/4 genotype.

How long will the treatment last?

78 weeks (one year and a half)

What your involvement will entail?
  • During the study, participants will be asked to complete tests that will assess their functioning, behaviour and quality of life (i.e. tests like ADAS-Cog)
  • Complete some laboratory tests to evaluate the emergent adverse effects (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)
  • During the study, participants will have to undergo brain scan (MRI) and CSF examination (spinal tap).

    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 80 years old
  • Have a diagnosis of mild cognitive impairment or mild dementia due to Alzheimer’s disease according to the National Institute on Aging/Alzheimer's Association core clinical criteria
  •  Carry on two copies of the ε4 allele of the apolipoprotein E gene (APOE4/4 homozygotes)

  • Have a score between 22 and 30 points in the MMSE test (a test about your memory) and a score of 0.5 to 1 in the Clinical Dementia Rating-Global Score (CDR). This would suggest that the person has an impairment in their memory that is at a mild stage
  • Have evidence of progressive memory loss over the last 12 months per investigator assessment.
Who cannot participate in the study?

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

  • Any medical or neurological condition (other than Alzheimer’s disease) that might be a contributing cause of the dementia or agitation
  • Participant who have a neurological condition other than Alzheimer’s disease that in the opinion of the investigator would interfere with the conduct of the study
  • Currently taking memantine
  • History of suicidal behavior within one year prior to screening History of seizures History of cerebral infarct or transient ischemic attack within one year prior to screening.

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

EudraCT Number

2020-005755-20

Clinicaltrials.gov identifier

NCT04770220

Study contact information

clinicaltrialsinfo@alzheon.com

Link to full text

https://www.clinicaltrials.gov/ct2/show/NCT04770220

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on March 2022.

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

 
Acknowledgement

Alzheimer Europe's Clinical Trials Watch database was developed as part of the 2018 Work Plan which received funding under an operating grant from the European Union’s Health Programme (2014–2020).

Alzheimer Europe gratefully acknowledges the support of its corporate sponsors for the update and maintenance of the database.

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