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ALZ-801

Phase II trials

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Study Information

Name of the study

Biomarker Effects of ALZ-801 in APOE4 Carriers With Early Alzheimer's Disease

Study sponsor

Alzheon Inc.

Disease

Early Alzheimer's disease

Phase

Phase II

Information about the drug that will be tested in the studies

Name of the drug

ALZ-801

Administration

A tablet taken orally once a day for two weeks and twice daily thereafter.

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

No

Will all participants receive the same drug?

Yes, all the participants will receive the same drug: a tablet of ALZ-801 (265mg).

Information about participating in the trial

What are the researchers trying to find out?

The purpose of the study is to evaluate the efficacy, safety and tolerability of ALZ-801 in people with early Alzheimer’s disease who have the genotype most at risk for Alzheimer's disease (APOE4/4 or APOE3/4 genotype).

How long will the treatment last? 

About 2 years.

What will your involvement entail?

  • During the study, participants will have to complete a PET brain scan or CSF examination (lumbar puncture) 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 and personal care (this is a test called CDR)
  • Participants will also need to complete some other tests to evaluate their thinking skills, behaviour, function and quality of life (e.g. RAVLT, DSST, A-IADL, MMSE).

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 80 years old
  • Have a diagnosis of probable Alzheimer’s disease dementia or mild cognitive impairment due 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
  • Have a genotype at risk for Alzheimer's disease (who carry the ε4 Variant of the Apolipoprotein E Gene (APOE4/4 or APOE3/4))
  • Have evidence of abnormal accumulation of amyloid in their brain (PET scan or CSF)
  • If the person is taking approved symptomatic medication for dementia (i.e. donepezil, rivastigmine or galantamine) the dosing regimen must have been stable.

Who cannot participate in the study?

Exclusion criteria include:

  • Brain scans showing significant abnormality
  • Any other type of neurological disease that is not Alzheimer’s disease (e.g. epilepsy)
  • A current diagnosis of major depressive disorder
  • A current treatment of memantine.

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 

  • Czechia
  • The Netherlands

Estimated start date of recruitment

September 2020

Information for your doctor

EudraCT Number

2020-000986-17

Clinicaltrials.gov identifier

NCT04693520 

Study contact information

clinicaltrialsinfo@alzheon.com

Link to full text

https://www.clinicaltrials.gov/ct2/show/NCT04693520

The information contained in this document is based on information available on public registries (e.g. EU Clinical Trials Register 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.

 

 

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Last Updated: Monday 15 March 2021

 

 
 

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