A Study to Evaluate Safety and Tolerability of Different Doses and Efficacy of PQ912 in Subjects With MCI and Mild AD

  • STATUS
    Recruiting
  • End date
    Jul 2, 2023
  • participants needed
    250
  • sponsor
    Vivoryon Therapeutics AG
Updated on 2 February 2021

Summary

This is a phase 2B multicenter, randomized, double-blind, placebo-controlled, parallel group dose finding study to evaluate the safety, tolerability and efficacy of PQ912, an inhibitor of the glutaminyl cyclase enzyme, in 250 subjects with mild cognitive impairment and mild dementia due to Alzheimer 's Disease.

Description

In the parallel group dose finding part of the study the first 90 subjects will be randomized 1:1:1 between PQ912 300 mg BID, 600 mg BID, and placebo. When the 90th patient has completed the week 24 treatment visit, the DSMB will decide on the dose of PQ912 to be continued. The decision is based on safety findings only, no efficacy data will be considered. After the DSMB has reached a decision on the dose to be continued, all subjects randomized to receive PQ912 will be reallocated to this dose (1:1). The duration of Subjects participation in the study is either 48, 60, 72, 84 or 96 weeks of treatment (depending on time of randomization). Subjects recruited early into the study will be kept on treatment for 96 weeks or until the regular, scheduled study visit which is closest to the scheduled week 48 visit of the last subject recruited in the study, whichever comes first.

Details
Condition Early Alzheimers Disease, Mild Cognitive Impairment Due to AD
Treatment Placebo, PQ912
Clinical Study IdentifierNCT04498650
SponsorVivoryon Therapeutics AG
Last Modified on2 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 50 yrs and 80 yrs?
Gender: Male or Female
Do you have Early Alzheimers Disease?
Do you have any of these conditions: Do you have Early Alzheimers Disease??
Do you have any of these conditions: Do you have Early Alzheimers Disease??
Do you have any of these conditions: Mild Cognitive Impairment Due to AD or Early Alzheimers Disease?
Positive CSF AD biomarker signature according to the AA-NIA criteria
Clinical syndrome of MCI or mild dementia according to the AA-NIA Research Framework
A cognitive impairment in the WAIS IV Coding Test of at least 0.5 standard deviation below the normative data
Adequate visual and auditory abilities to perform the cognitive and functional assessments in the opinion of the investigator
Meeting the completion and performance criteria for the CogState NTB
Outpatient with study partner capable of accompanying the subject on all applicable clinic visits

Exclusion Criteria

Significant neurological or psychiatric disorders, other than AD, that may affect cognition
Atypical clinical presentations of MCI due to AD or mild dementia due to AD, such as the visual variant of AD (including posterior cortical atrophy), frontal variant or the language variant (including logopenic aphasia)
Moderate and severe dementia with a Mini-Mental State Examination score (MMSE) below 20\
Current presence of a clinically important major psychiatric disorder (e.g. major depressive disorder) as defined by DSM-5 criteria, or symptom(s) (e.g. hallucinations) that could affect the subject's ability to complete the study
History of clinically evident stroke
History of seizures within the last two years prior to the screening visit
Myocardial infarction within the last six months prior to screening
History of uncontrolled hypertension (in the opinion of the investigator) within six months prior to screening
Contraindication to lumbar puncture and MRI
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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