- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02389413
Safety and Tolerability of PQ912 in Subjects With Early Alzheimer's Disease (SAPHIR)
May 31, 2017 updated by: Vivoryon Therapeutics N.V.
A Phase 2A Multicentre, Randomised, Double Blind, Placebo-Controlled, Parallel-Group Safety and Tolerability Study of PQ912 in Subjects With Early Alzheimer's Disease
The aim of this study is to evaluate the safety, tolerability and preliminary efficacy of PQ912 in subjects with Mild Cognitive Impairment (MCI) due to Alzheimers Disease (AD) or mild dementia due to AD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hoboken, Belgium, 2660
- Ziekenhuis Netwerk Antwerpen / Geheugenkliniek
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Kuopio, Finland, 70211
- Kliininen tutkimuskeskus
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Oulu, Finland, 90220
- Oulu University Hospital
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Turku, Finland, 20520
- CRST Oy
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Bordeaux, France, 33076
- CHU Bordeaux Pellegrin (CMRR)
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Dijon, France, 21079
- CHU François Mitterand (Centre Mémoire Ressources Recherche (CMRR))
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Lille Cedex, France, 59037
- CHRU de Lille / Hôpital Roger Salengro
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Toulouse Cedex 9, France, 31059
- Hôpital La Grave / Centre de Recherche Clinique
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Berlin, Germany, 10450
- Charité - Universitätsmedizin Berlin
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Göttingen, Germany, 37075
- Universitätsmedizin Göttingen / Klinik für Psychiatrie und Psychotherapie
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Halle (Saale), Germany, 06112
- Universitätsklinikum Halle (Saale) Klinik und Poliklinik für Psychiatrie, Psychotherapie und Psychosomatik
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Leipzig, Germany, 04107
- Arzneimittelforschung Leipzig GmbH
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Magdeburg, Germany, 39120
- Universitätsklinikum Magdeburg / Institut für Kognitive Neurologie und Demenzforschung
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München, Germany, 81675
- Klinikum rechts der Isar der TU München / Klinik für Psychiatrie und Psychotherapie
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Münster, Germany, 48149
- Universitätsklinikum Münster / Klinik für Allgemeine Neurologie
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Rostock, Germany, 18147
- Universitätsmedizin Rostock / Zentrum für Nervenheilkunde/ Klinik für Psychosomatik und Psychotherapeutische Medizin
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Ulm, Germany, 89081
- Neurologische Universitätsklinik Ulm
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Amsterdam, Netherlands, 1081 GM
- Alzheimer Research Center
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Barcelona, Spain, 08025
- Hospital de la Santa Creu i Sant Pau, Neurology Department, Memory Unit
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Barcelona, Spain, 08028
- Fundació ACE. Institut Català de Neurociències Aplicades
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Santiago de Compostela, Spain, 15706
- Complexo Hospitalario Universitario de Santiago (CHUS)
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Sevilla, Spain, 41009
- Hospital Universitario Virgen Macarena
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Mölndal, Sweden, 43141
- Verksamheten för neuropsykiatri Sahlgrenska universitetssjukhuset
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Major Inclusion Criteria:
- Signed and dated written informed consent
- Male or surgically sterile or postmenopausal female aged ≥ 50 to ≤ 89 years. Male subjects with childbearing potential partners are willing to and should use condoms during treatment and until 28 days of the last dose of study medication.
- Diagnosis of MCI due to AD or mild dementia due to AD with amnestic presentation, according to AA-NIA (Alzheimer's Association (AA) and the National Institute on (Aging NIA) criteria [Albert et al 2011; McKhann et al 2011]
- Mini-Mental State Examination (MMSE) score of 21 to 30 inclusive at screening
A positive AD signature showing one of the following (either a, b, c, OR d):
- Screening CSF sample with an A-beta 42 concentration of less than 638 ng/L AND total tau >375 ng/L, as assessed by central laboratory.
- Screening CSF sample with an A-beta 42 concentration of less than 638 ng/L AND p-tau > 52 ng/L, as assessed by central laboratory.
- Tau/A-beta ratio > 0.52, as assessed by central laboratory.
- A positive amyloid PET if available prior to screening.
- Treatment naïve, this means not having received any prior established specific treatment for MCI due to AD or mild dementia due to AD including no (prior) use of an acetylcholinesterase inhibitor or memantine. A maximum of two months of prior cumulative treatment with an acetylcholinesterase inhibitor or memantine is allowed if the acetylcholinesterase inhibitor or memantine was discontinued due to intolerance, and if this was done at least two months prior to baseline. Use of Souvenaid will be allowed if Souvenaid was discontinued at least twomonths prior to baseline, or if the subject is on stable dose for at least six months prior to baseline and is willing to continue during the study on the same dose and frequency.
- Outpatient with study partner capable of accompanying the subject on all clinic visits. In accordance to Swedish regulations availability of study partner is not applicable for Sweden.
Major Exclusion Criteria:
- Significant neurologic disease, 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) or the language variant (including logopenic aphasia).
Concomitant disorders:
- Severe hepatic (Child-Pugh C) and/or kidney failure (creatinine clearance (estimated Glomerular Filtration Rate - eGFR) ≤ 30 ml/min/1.73m2) and/or serum creatinine above 1.5 fold of Upper Limit Normal (ULN) and/or Alanine-Amino Transferase (AST) or Asparagine-Amino Transferase (ALT) above 3 fold ULN at baseline.
- History of or screening visit brain MRI scan indicative of any other significant abnormality.
- 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.
- . Current clinically important systemic illness that is likely to result in clinically relevant deterioration of the subject's condition or might affect the subject's safety during the study.
- Other clinically important diseases or conditions or abnormalities of vital signs, physical examination, neurologic examination, laboratory results, or electrocardiogram (ECG) examination (e.g. atrial fibrillation) that could compromise the study or the safety of the subject.
- Clinically important infection within 30 days prior to screening e.g. chronic persistent or acute infection, such as bronchitis or urinary tract infection.
- Any known hypersensitivity to any of the excipients contained in the test article formulation.
- Severe hepatic failure (Child-Pugh C) OR kidney failure (creatinine clearance (eGFR) ≤ 30 ml/min/1.73m2) OR serum creatinine above 1.5 fold of ULN OR AST or ALT above 3 fold of ULN at screening.´
- Concomitant Medication/Therapies:
The following therapies are not permitted for the given intervals prior to baseline and until End-of-treatment (EOT):
- Use of experimental medications for AD or any other investigational medications or devices for treatment of indications other than AD within 60 days prior to baseline.
- Treatment with Souvenaid, except if the use of Souvenaid was discontinued at least two months prior to baseline, or if the subject is on stable dose for at least six months prior to baseline and is willing to continue the use of Souvenaid during the study on the same dose and frequency.
- Concomitant treatment with St. John's Wort (a wash out phase of at least two weeks prior to baseline is required).
- Any concomitant treatment which impairs cognitive function and cannot be washed out at least four weeks prior to baseline.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: PQ912 oral
PQ912 will be administered orally twice daily for 12 weeks.
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Placebo Comparator: Placebo
Placebo will be administered orally twice daily for 12 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Frequency of adverse events and serious adverse events (the study is a Phase II safety trial)
Time Frame: 12 weeks
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Exploratory clinical measures (measured by a questionnaire)
Time Frame: 12 weeks
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Mini-Mental State Examination (MMSE) Letter Fluency Test (LFT) Category Fluency Test (CFT) Geriatric Depression Scale (GDS) Cogstate Neuropsychological Test Battery
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12 weeks
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Change from baseline of a panel of concept and AD-related biomarkers in Cerebrospinal fluid (CSF) (measured by Analysis of several biochemical assays)
Time Frame: 12 weeks
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QC activity, total-tau, phospho-tau, Abeta pattern, pro-inflammatory panel
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12 weeks
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Change from baseline in brain functional connectivity (measured by Magnetic Resonance Imaging (MRI) analysis)
Time Frame: 12 weeks
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12 weeks
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Change from baseline in functional connectivity and network Analysis in electroencephalography (EEG)
Time Frame: 12 weeks
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12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Frank Weber, Dr., Vivoryon Therapeutics N.V.
- Study Chair: Philip Scheltens, Prof. Dr., VUmc Alzheimer Centre (p: +31 20 4440816)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
April 1, 2017
Study Completion (Actual)
April 1, 2017
Study Registration Dates
First Submitted
March 5, 2015
First Submitted That Met QC Criteria
March 16, 2015
First Posted (Estimate)
March 17, 2015
Study Record Updates
Last Update Posted (Actual)
June 1, 2017
Last Update Submitted That Met QC Criteria
May 31, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBD01071
- 2014-001967-11 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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