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A Trial to Evaluate the Efficacy and Safety of PQ912 in Patients With Early AD (VIVA-MIND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03919162
Recruitment Status : Not yet recruiting
First Posted : April 18, 2019
Last Update Posted : September 18, 2020
Sponsor:
Collaborators:
Alzheimer's Disease Cooperative Study (ADCS)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Vivoryon Therapeutics AG

Brief Summary:
This is a seamless phase 2A-B multi-center, randomized, double blind, placebo-controlled, parallel group study of PQ912, an inhibitor of the glutaminyl cyclase enzyme. Phase 2A includes adaptive dosing evaluation of three dose levels with exposure at full dose for 8 weeks, and phase 2B assesses efficacy and longer-term safety through 72 weeks of treatment. An interim futility analysis is planned when half the study sample (n=230) has completed the week 48 visit or dropped out.

Condition or disease Intervention/treatment Phase
Early Alzheimer's Disease Drug: PQ912 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 462 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Seamless Phase 2A-B Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of PQ912 in Patients With Early Alzheimer's Disease
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 600 mg
First 4 weeks 150 mg BID, week 5-8 300 mg BID, week 9-16 600 mg BID
Drug: PQ912
PQ912 150 mg tablets

Experimental: 300 mg
First 4 weeks 150 mg BID, week 5-12 300 mg BID
Drug: PQ912
PQ912 150 mg tablets

Experimental: 150 mg
8 weeks on 150 mg BID
Drug: PQ912
PQ912 150 mg tablets

Placebo Comparator: Placebo Other: Placebo
Placebo tablets to mimic PQ912 150 mg tablets




Primary Outcome Measures :
  1. 2A Primary safety: proportion of participants who experience any drug-related adverse event of interest (DAE-I). [ Time Frame: 16 weeks ]
    The primary objective in phase 2A is to determine the highest safe and well-tolerated dose over the safety period (8 weeks at full dose) which will include the proportion of participants who experience any drug-related adverse event of interest (DAE-I).

  2. 2A Primary PK [ Time Frame: 16 weeks ]
    The pharmacokinetics (PK) objectives in Phase 2A are to assess PQ912 levels in plasma after 8 weeks at full dose and calculate the target occupancy (TO) in CSF as 'go-no-go' criteria for the dose decision.

  3. 2B Primary efficacy: CDR-SoB scale, a measure of cognition and function [ Time Frame: 72 weeks ]

    The primary endpoint in phase 2B is the within-participant change from baseline to week 72 in Clinical Dementia Rating Scale Sum of Boxes score, compared between active arm and placebo. The CDR-SoB scale is a five point score, with the following 5 possible scores:0 = Normal

    0.5 = Very Mild Dementia

    1. = Mild Dementia
    2. = Moderate Dementia
    3. = Severe Dementia


Secondary Outcome Measures :
  1. Key secondary efficacy: CFC2, a cognitive-functional composite [ Time Frame: 72 weeks ]
    The key secondary objective in phase 2B is to evaluate the efficacy of PQ912 as measured by CFC2, a cognitive-functional composite, over a 72-week treatment period.



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Ages Eligible for Study:   50 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed as having Mild Cognitive Impairment (MCI) due to Alzheimer's disease (AD) or Mild probable AD according to workgroups of the Diagnostic Guidelines of the National Institute on Aging and Alzheimer's Association (NIA-AA)
  • Mini-Mental State Examination (MMSE) score 20-30 inclusive at screening.
  • Montreal Cognitive Assessment score (MoCA) < 26 (add 1 point to the MoCA score for participants with < 12 years of education)
  • Clinical Dementia Rating score 0.5 or 1 with memory score of > 0.5.
  • Positive CSF AD biomarker signature

Exclusion Criteria:

  • Significant neurodegenerative diseases, other than AD
  • Meeting Diagnostic Criteria for Possible AD
  • Hepatic impairment defined as Child-Pugh class A or more severe liver impairment
  • History of moderate or severe skin reactions to medications or current moderate or severe disease of the skin and subcutaneous tissues
  • History of a major depressive episode within the past 6 months of screening
  • History of diagnosis of schizophrenia
  • History of uncontrolled bipolar disorder within past five years of screening
  • History of seizures within past two years of screening
  • Contraindication to lumbar puncture and MRI

Information from the National Library of Medicine

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): NCT03919162


Contacts
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Contact: Carolyn Revta +1 858-229-4697 vivamind@vivoryon.com
Contact: Kerstin Kuehn-Wache +49 345 5559900 clinics@vivoryon.com

Sponsors and Collaborators
Vivoryon Therapeutics AG
Alzheimer's Disease Cooperative Study (ADCS)
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Howard Feldman Alzheimer's Disease Cooperative Study (ADCS)
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Responsible Party: Vivoryon Therapeutics AG
ClinicalTrials.gov Identifier: NCT03919162    
Other Study ID Numbers: PBD-01187
1R01AG061146-01 ( U.S. NIH Grant/Contract )
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders