Status:
COMPLETED
A Study to Evaluate Safety and Tolerability of Different Doses and Efficacy of PQ912 in Subjects With MCI and Mild AD
Lead Sponsor:
Vivoryon Therapeutics N.V.
Collaborating Sponsors:
Nordic Bioscience A/S
Amsterdam UMC, location VUmc
Conditions:
Early Alzheimers Disease
Mild Cognitive Impairment Due to AD
Eligibility:
All Genders
50-80 years
Phase:
PHASE2
Brief 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 glutamin...
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 t...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
July 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2024
Estimated Enrollment :
259 Patients enrolled
Trial Details
Trial ID
NCT04498650
Start Date
July 6 2020
End Date
January 12 2024
Last Update
March 12 2024
Active Locations (21)
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1
Sanos Clinics
Ganderup, Denmark
2
Sanos Clinics
Herlev, Denmark
3
Sanos Clinics
Vejle, Denmark
4
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10450