PLEODIAL-I

CompletedPhase 2

Pilot Study Assessing the Effects of PXT00864 in Patients With Mild Alzheimer Disease (AD)

First Single-blind Sequential Placebo-controlled Prospective Phase IIA Pilot Study Assessing the Effects of PXT00864 in Mild AD Patients

Lead sponsor

Pharnext S.C.A.

Asset

PXT00864

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 20-26•Study partner/caregiver required

Primary endpoints

•ADAS-Cog•Number of Treatment Emergent Adverse Events (TEAEs)

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

Org study IDCLN-PXT00864-03

NCT IDNCT02361424

Timeline

Milestones

Study start2013-02 (month precision)

Study first posted2015-02-11estimated

Primary completion2015-06actual (month precision)

Study completion2015-06actual (month precision)

Last update posted2016-02-15estimated

Assets

Drug assets

PXT00864

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female patients aged ≥ 60 years.

•Patient with a diagnosis of probable AD

•Progressive decline in cognition for more than six months which story is documented in patient medical records

•A Mini-Mental State Examination (MMSE) score of 20-26

•With a minimum of educational background

•Naïve to anti-dementia treatment

•MRI assessment which corroborates the clinical diagnosis (hippocampal atrophy) and excludes other potential causes of dementia especially cerebrovascular lesions

•If available, Cerebral Spinal Fluid (CSF) classical biomarkers should be at levels which corroborate the clinical diagnosis

•Ambulatory patient living at home with a caregiver available and living in the same household or interacting with the patient daily and available if necessary to ensure administration of the investigational product

•Absence of major or severe depressive disease

•Patient with a willingness to participate in this study and who have signed an informed consent form

Exclusion criteria

•Early onset of dementia, i.e. before 60 years old to avoid hereditary AD forms

•Significant neurological disease other than AD

•Major psychiatric disorder or syndrome (schizophrenia or bipolar disorder)

•Seizure disorders

•Other infectious, metabolic or systemic diseases affecting central nervous system

•Other active clinically significant illness

•Hospitalization or change of chronic concomitant medications one month prior to screening

•Patients with severe respiratory, hepatic or renal failure or with any other significantly potentially disabling abnormality detected during screening

•Known hypersensitivity to the tested treatment including active substance and excipients.

•Patients participating in another study and exposed to any investigational therapy within the 30 days prior to the entry in this study.

•Patient without medical care insurance

Endpoints (13)

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

Other (unclassified)

Executive function / language

Global cognition

Memory

Function / daily living

Behavior / neuropsychiatric

Safety / tolerability / PK

Global cognition

2 endpoints

Primary/protocol endpoint

Change From Baseline in the total score of the 11-item Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)

Time frame:Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in the score of the Clinical Dementia Rating (CDR) scale

Time frame:1 (baseline) and V4 (end of study, after 12 weeks of treatment)

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Memory

1 endpoint

Secondary/protocol endpoint

Change From Baseline in the score of the Free and Cued Selective Reminding Test (FCSRT)

Time frame:1 (baseline) and V4 (end of study, after 12 weeks of treatment)

change from baseline, improvement

Executive function / language

3 endpoints

Secondary/protocol endpoint

Change From Baseline in the score of the Digit Symbol Substitution Test (DSST)

Time frame:Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in the time score of the Trail Making Test - part A

Time frame:Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in the time score of the Trail Making Test - part B

Time frame:Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)

change from baseline, improvement

Function / daily living

1 endpoint

Secondary/protocol endpoint

Change From Baseline in the score of the 4-item Instrumental Activities of Daily Living scale (IADL-PAQUID)

Time frame:V0 (train), V1 (baseline), and every 4 weeks (V2, V3 and V4)

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Change From Baseline in the score of the Apathy Inventory (AI) scale

Time frame:1 (baseline) and V4 (end of study, after 12 weeks of treatment)

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:throughout the 12-week study period.

event count, event

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Change From Baseline in the speed to perform the Zazzo's Cancellation Test

Time frame:Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in the score of the Zazzo's Cancellation Test

Time frame:Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in the score of the 15-second Isaacs Set Test

Time frame:Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change From Baseline in the cognitive Event Related Potential parameters (optional)

Time frame:V1 (baseline), and every 4 weeks (V2, V3 and V4)

change from baseline, improvement

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.