VIVIAD

CompletedPhase 2

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

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.

Lead sponsor

Vivoryon Therapeutics N.V.

Asset

PQ912

Listed sites

Recruiting sites

Enrollment

259

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•Study partner/caregiver required•MRI contraindications excluded

Primary endpoints

•Primary safety•Primary efficacy

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2019-003532-23

NCT IDNCT04498650

Org study IDPBD-01180

Timeline

Milestones

Study start2020-07-06actual

Study first posted2020-08-04actual

Primary completion2023-12-18actual

Study completion2024-01-12actual

Last update posted2024-03-12actual

Assets

Drug assets

PQ912

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

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

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

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Fluid / digital biomarkers

Memory

Safety / tolerability / PK

Other (unclassified)

Memory

1 endpoint

Primary/protocol endpoint

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

Time frame:48 weeks and EoT (96 weeks at maximum)

descriptive

Fluid / digital biomarkers

2 endpoints

Secondary/protocol endpoint

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.

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

change from baseline, improvement

Other/protocol endpoint

Exploratory efficacy - The within-participants change from baseline in a set of representative functional network topology EEG measures compared between active arms and placebo.

Time frame:48 weeks

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

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

threshold achievement, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

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

Time frame:48 weeks and EoT (96 weeks at maximum)

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.
PMID34425883via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.