A Study to Evaluate Safety and Tolerability of Different Doses and Efficacy of PQ912 in Subjects With MCI and Mild AD (VIVIAD)
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ClinicalTrials.gov Identifier: NCT04498650 |
Recruitment Status :
Recruiting
First Posted : August 4, 2020
Last Update Posted : February 2, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Early Alzheimers Disease Mild Cognitive Impairment Due to AD | Drug: PQ912 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 250 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
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. |
Actual Study Start Date : | July 6, 2020 |
Estimated Primary Completion Date : | May 2023 |
Estimated Study Completion Date : | July 2023 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo |
Drug: Placebo
Placebo tablets to mimic PQ912 50 mg and 150 mg tablets |
Experimental: 300 mg
Dose 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
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Drug: PQ912
PQ912 50 mg tablets and 150 mg tablets
Other Name: varoglutamstat |
Experimental: 600 mg
Dose 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
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Drug: PQ912
PQ912 50 mg tablets and 150 mg tablets
Other Name: varoglutamstat |
- 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 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
- 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) ]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
- 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) ]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.
- 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) ]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
- 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 ]
Evaluation of brain functional network activity and connectivity will be performed using quantitative EEG measurements, as described by (Briels et al. 2020; Poil et al. 2013; Scheltens et al. 2018) Global relative power in the delta (0.5 - 4 Hz), alpha (8 -13 Hz) and beta (13 - 30Hz) frequency bands
- Global posterior dominant peak frequency
- Amplitude Envelope Correlation (AEC) in the 4- 13 Hz band Functional network topology measures such as centrality, modularity, minimum spanning tree.

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Ages Eligible for Study: | 50 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04498650
Contact: Katharina Fuchs | +49 5559900 | clinics@vivoryon.com | |
Contact: Kerstin Kuehn-Wache | +49 5559900 | clinics@vivoryon.com |
Denmark | |
Sanos Clinics | Recruiting |
Ganderup, Denmark | |
Contact: Hanne Soerensen | |
Principal Investigator: Pernille Luehdorf, MD | |
Sanos Clinics | Recruiting |
Herlev, Denmark | |
Contact: Charlotta Arpi | |
Principal Investigator: Ulla Schmidt, MD | |
Sanos Clinics | Recruiting |
Vejle, Denmark | |
Contact: Ellen Frank | |
Principal Investigator: Peter Alexandersen, MD | |
Germany | |
Charité - Universitätsmedizin Berlin | Recruiting |
Berlin, Germany, 10450 | |
Contact: Katja Lindner | |
Principal Investigator: Oliver Peters, MD | |
Universitätsklinikum Schleswig-Holstein (UKSH), Klinik für Neurologie | Recruiting |
Kiel, Germany, 24105 | |
Contact: Katrin Lange | |
Principal Investigator: Thorsten Bartsch, MD | |
Universitätsklinikum Magdeburg / Institut für Kognitive Neurologie und Demenzforschung | Recruiting |
Magdeburg, Germany, 39120 | |
Contact: Urte Schneider | |
Principal Investigator: Emrah Duezel, MD | |
Institut für Studien zur Psychischen Gesundheit (ISPG) | Recruiting |
Mannheim, Germany, 68165 | |
Contact: Dörthe Hafke | |
Principal Investigator: Georg Adler, MD | |
Klinikum rechts der Isar der TU München / Klinik für Psychiatrie und Psychotherapie | Recruiting |
München, Germany, 81675 | |
Contact: Karin Liebl | |
Principal Investigator: Timo Grimmer, MD | |
Universitätsklinikum Münster / Klinik für Allgemeine Neurologie | Recruiting |
Münster, Germany, 48149 | |
Contact: Gloria Lwanga | |
Principal Investigator: Matthias Pawlowski, MD | |
Klinik für Neurologie Universitätsklinikum Ulm | Recruiting |
Ulm, Germany, 89081 | |
Principal Investigator: Doerte Polivka, MD | |
Netherlands | |
Brain Research Center | Recruiting |
Amsterdam, Netherlands | |
Contact: Femke van der Linden | |
Principal Investigator: Sterre Rutgers, MD | |
Brain Research Center | Recruiting |
Den Bosch, Netherlands | |
Contact: Hetty Den Burger | |
Principal Investigator: Paul Dautzenberg, MD | |
Brain Research Center Zwolle | Recruiting |
Zwolle, Netherlands, 8025 | |
Contact: Carlie Dille-Amo | |
Principal Investigator: Niels Prins, MD | |
Spain | |
Neurology (Memory Unit) - Hospital de la Santa Creu i Sant Pau | Recruiting |
Barcelona, Spain, 08025 | |
Contact: Andrea Subirana | |
Principal Investigator: Alberto Lleo, MD | |
Fundació ACE | Recruiting |
Barcelona, Spain, 08028 | |
Contact: Mar Buendia | |
Principal Investigator: Merce Boada, MD | |
Unidad de Neurociencias. Hospital Victoria Eugenia | Recruiting |
Seville, Spain, 41009 | |
Contact: Angelles Barro | |
Principal Investigator: Felix Vinuela, MD |
Study Chair: | Philip Scheltens | Amsterdam UMC, location VUmc |
Responsible Party: | Vivoryon Therapeutics N.V. |
ClinicalTrials.gov Identifier: | NCT04498650 |
Other Study ID Numbers: |
PBD-01180 2019-003532-23 ( EudraCT Number ) |
First Posted: | August 4, 2020 Key Record Dates |
Last Update Posted: | February 2, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Alzheimer Disease Cognitive Dysfunction Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Cognition Disorders |