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SAPHIR

CompletedPhase 2

Safety and Tolerability of PQ912 in Subjects With Early Alzheimer's Disease

A Phase 2A Multicentre, Randomised, Double Blind, Placebo-Controlled, Parallel-Group Safety and Tolerability Study of PQ912 in Subjects With Early Alzheimer's Disease

Asset

PQ912

Listed sites

23

Recruiting sites

-

Enrollment

120

actual

Study population

Alzheimer’s disease

Key I/E criteria

•MCI due to AD•Amyloid biomarker required (PET)•MMSE 21-30•Study partner/caregiver required•AD symptomatic therapy: stable

Primary endpoint

•Adverse events and serious adverse events

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 number2014-001967-11
NCT IDNCT02389413
Org study IDPBD01071

Timeline

Milestones

Study start2015-03 (month precision)
Study first posted2015-03-17estimated
Primary completion2017-04actual (month precision)
Study completion2017-04actual (month precision)
Last update posted2017-06-01actual

Assets

Drug assets

PQ912

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age89 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

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):

1. 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.

2. 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.

3. Tau/A-beta ratio > 0.52, as assessed by central laboratory.

4. 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

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.

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

Neuroimaging
2
Global cognition
1
Amyloid biomarkers
1
Safety / tolerability / PK
1

Global cognition

1 endpoint
Secondary/protocol endpoint

Exploratory clinical measures (measured by a questionnaire)

Time frame:12 weeks

Mini-Mental State Examination (MMSE)

categorical status, descriptive

Amyloid biomarkers

1 endpoint
Secondary/protocol endpoint

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

change from baseline, improvement

Neuroimaging

2 endpoints
Secondary/protocol endpoint

Change from baseline in brain functional connectivity (measured by Magnetic Resonance Imaging (MRI) analysis)

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in functional connectivity and network Analysis in electroencephalography (EEG)

Time frame:12 weeks

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Frequency of adverse events and serious adverse events (the study is a Phase II safety trial)

Time frame:12 weeks

event count, event

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

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.