AzTrials
AzTrials

Early Alzheimers DiseasePhase 2VIVIADNCT04498650

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

A Phase 2 study testing PQ912 in people with Early Alzheimers Disease and Mild Cognitive Impairment Due to AD, run by Vivoryon Therapeutics N.V. at 21 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 years
What is being tested?
PQ912
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
259 participants
Where
21 sitesin 5 countries
Study dates
6 Jul 2020to 12 Jan 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  • 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

Main 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

Trial locations and contacts

21 sites in 5 countries.

21 sites in 5 countries

Germany7 sites

  • Charité - Universitätsmedizin Berlin

    Berlin, 10450

  • Universitätsklinikum Schleswig-Holstein (UKSH), Klinik für Neurologie

    Kiel, 24105

  • Universitätsklinikum Magdeburg / Institut für Kognitive Neurologie und Demenzforschung

    Magdeburg, 39120

  • Institut für Studien zur Psychischen Gesundheit (ISPG)

    Mannheim, 68165

  • Klinikum rechts der Isar der TU München / Klinik für Psychiatrie und Psychotherapie

    München, 81675

  • Universitätsklinikum Münster / Klinik für Allgemeine Neurologie

    Münster, 48149

  • Klinik für Neurologie Universitätsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Poland4 sites

  • Podlaskie Centrum

    Bialystok, 15-756

  • SOMED CR

    Lodz, 90-368

  • Klinika Psychiatrii Wieku Podeszłego i Zaburzeń Psychotycznych Uniwersytetu Medycznego w Łodzi

    Lodz, 92-216

  • SOMED CR

    Warsaw, 01-737

Other trials in Poland

Spain4 sites

  • Neurology (Memory Unit) - Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Fundació ACE

    Barcelona, 08028

  • Cae Oroitu

    Getxo, 48993

  • Unidad de Neurociencias. Hospital Victoria Eugenia

    Seville, 41009

Other trials in Spain

Denmark3 sites

  • Sanos Clinics

    Ganderup

  • Sanos Clinics

    Herlev

  • Sanos Clinics

    Vejle

Other trials in Denmark

Netherlands3 sites

  • Brain Research Center

    's-Hertogenbosch

  • Brain Research Center

    Amsterdam

  • Brain Research Center Zwolle

    Zwolle, 8025

Other trials in Netherlands

About this study

Official title: A Phase 2b Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Dose Finding, Safety, Tolerability and Efficacy Study of PQ912 in Subjects With MCI and Mild Dementia Due to Alzheimer's Disease.

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.

Read the detailed 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.

Being tested
PQ912, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PQ912Drug

    Also called varoglutamstat

    PQ912 50 mg tablets and 150 mg tablets

  • PlaceboDrug

    Placebo tablets to mimic PQ912 50 mg and 150 mg tablets

Study groups in NCT04498650
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
300 mgExperimentalDose in weeks 1 and 2: 50 mg once daily (evening) Dose in weeks 3 and 4: 50 mg BID Dose in weeks 5-8: 150 mg BID Dose in weeks 9-24: 300 mg BID
Receives: Drug: PQ912
600 mgExperimentalDose in weeks 1 and 2: 50 mg once daily (evening) Dose in weeks 3 and 4: 50 mg BID Dose in weeks 5-8: 150 mg BID Dose in weeks 9-12: 300 mg BID Dose in weeks 12-24: 600 mg BID
Receives: Drug: PQ912

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary safety: The proportion of participants who experience any Adverse Event (AE), Serious Adverse Event (SAE), Adverse Event of Interest (AE-I)

    The safety analysis will include the number of subjects with, and the number of any AE, any SAE (both overall and related), AEs leading to discontinuation of treatment, AEs leading to temporary treatment interruption, treatment compliance, the number of subjects with AEs of interest as defined above, the severity, duration and outcome of AEs

    Measured: 48 weeks

  2. Primary efficacy: within-participant linear change with time of the combinded z-score for cognition compared between active arm and placebo.

    The within-participant change over time in cognition measured by the combined z-score of the Detection test, Identification test and the 'One Back' test (attention and working memory domains) of the Neurological Test Battery

    Measured: 48 weeks and EoT (96 weeks at maximum)

Secondary outcomes (2)

  1. Secondary efficacy: The within-participant linear change from baseline to week 48 in quantitative EEG (global relative theta wave power), compared between active and placebo.

    Using a quantitative EEG the within-participant change from baseline to week 48 of the global relative theta wave power (4-8 Hz) will serve as a primary efficacy outcome.

    Measured: 48 weeks at minimum or until EoT (96 weeks at maximum)

  2. Secondary efficacy: The within-participant linear change with time in overall cognition as measured by the CogState Brief Battery (CBB) Z-score compared between active arm and placebo

    he within-participant linear change with time in overall cognition as measured by the CBB (CogState Detection, Identification, One Card Learning and One Back test) -Z-score

    Measured: 48 weeks and EoT (96 weeks at maximum)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2020
  2. Study start6 Jul 2020
  3. Primary completion18 Dec 2023
  4. Study completion12 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
259 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04498650
Sponsor's protocol ID
PBD-01180
Other IDs
2019-003532-23, 2019
Acronym
VIVIAD
Status last verified
Mar 2024
First submitted
21 Jul 2020
Last updated
12 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Vijverberg EGB, Axelsen TM, Bihlet AR, Henriksen K, Weber F, Fuchs K, Harrison JE, Kuhn-Wache K, Alexandersen P, Prins ND, Scheltens P. Rationale and study design of a randomized, placebo-controlled, double-blind phase 2b trial to evaluate efficacy, safety, and tolerability of an oral glutaminyl cyclase inhibitor varoglutamstat (PQ912) in study participants with MCI and mild AD-VIVIAD. Alzheimers Res Ther. 2021 Aug 23;13(1):142. doi: 10.1186/s13195-021-00882-9.

    PubMed 34425883

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PQ912 in people with Early Alzheimers Disease and Mild Cognitive Impairment Due to AD, run by Vivoryon Therapeutics N.V. at 21 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Germany, Poland, Spain, Denmark, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary safety: The proportion of participants who experience any Adverse Event (AE), Serious Adverse Event (SAE), Adverse Event of Interest (AE-I) (time frame: 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04498650, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in