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PLEODIAL-II

CompletedPhase 2

24-week Open-label Extension Study Evaluating PXT00864 Effect in Mild AD Patients Further to PLEODIAL-I Completion

24-week Open-label Extension Study Evaluating the Effect of PXT00864 in Mild Alzheimer's Disease Patients Further to PLEODIAL-I Completion

Lead sponsor

Pharnext S.C.A.

Asset

PXT00864

Listed sites

1

Recruiting sites

-

Enrollment

45

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age ≥60

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-PXT00864-04
NCT IDNCT02361242

Timeline

Milestones

Study start2013-06 (month precision)
Study first posted2015-02-11estimated
Primary completion2015-12actual (month precision)
Study completion2015-12actual (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

Main Inclusion Criteria:

•Mild Alzheimer's Disease patient who was included in PLEODIAL-I study
•Mini Mental State Examination (MMSE) score greater or equal to 20

Exclusion criteria

•Patient who was not compliant with the previous PLEODIAL-I study protocol
•Patient who experienced significant adverse events which necessitated treatment discontinuation during the PLEODIAL-I study

Endpoints (2)

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

Global cognition
1
Safety / tolerability / PK
1

Global cognition

1 endpoint
Primary/protocol endpoint

Change from Baseline in the total score of the 11-items Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)

Time frame:V5 (study entry), V6 (after 12 weeks), V7 (after 24 weeks)

ADAS-Cog

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:throughout the 24-week study period

event count, event

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.