CompletedPhase 2

Safety and Effect on Memory of PYM50028 in Mild Alzheimer's Disease

Phase II Randomised, Double Blind, Placebo Controlled, Parallel Group Study to Investigate the Safety, Effect on Cognition and Pharmacokinetic Profile of PYM50028 in Subjects With Mild Dementia of the Alzheimer's Type

Lead sponsor

Phytopharm

Asset

PYM50028

Listed sites

Recruiting sites

Enrollment

250

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE ≥16

Primary endpoints

•Hopkins verbal learning test (revised) total word recall after 12 weeks•Cambridge neuropsychological test automated battery (CANTAB) paired associate

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

NCT IDNCT00130429

Org study IDP58/09ME/03/04

Timeline

Milestones

Study start2004-01 (month precision)

Study first posted2005-08-15estimated

Study completion2005-09actual (month precision)

Last update posted2009-08-21estimated

Assets

Drug assets

PYM50028

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•At least 50 years of age

•Diagnosis of possible or probable Alzheimer's disease

•Mini mental state examination score at least 16

•Good understanding of both written and verbal English

•A recent head scan that is consistent with the diagnosis of Alzheimer's disease

Exclusion criteria

•Recent history or clinical evidence of significant neurological disease other than dementia due to Alzheimer's disease

•Known to have another condition that is associated with dementia

•Use of psychotropic medication within the previous 4 weeks (excluding cholinesterase inhibitors, selective serotonin reuptake inhibitors and venlafaxine)

•Hormone replacement therapy started or changed within the previous 6 months

•Received any investigational drugs within the previous 12 weeks

Endpoints (9)

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

Memory

Other (unclassified)

Global cognition

Function / daily living

Global cognition

2 endpoints

Secondary/protocol endpoint

Mini mental state examination score

Mini-Mental State Examination (MMSE)

descriptive

Secondary/protocol endpoint

Clinical dementia rating (overall and sum of boxes)

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

descriptive

Memory

3 endpoints

Primary/protocol endpoint

Hopkins verbal learning test (revised) total word recall after 12 weeks

descriptive

Primary/protocol endpoint

Cambridge neuropsychological test automated battery (CANTAB) paired associate learning (Phytopharm modified form) total adjusted error score after 12 weeks

descriptive

Secondary/protocol endpoint

CANTAB spatial working memory within error, between error and strategy scores

descriptive

Function / daily living

1 endpoint

Secondary/protocol endpoint

Disability assessment for dementia score

descriptive

Other (unclassified)

3 endpoints

Secondary/protocol endpoint/low confidence

CANTAB rapid visual information processing (RVIP) mean latency

descriptive

Secondary/protocol endpoint/low confidence

CANTAB RVIP total correct hits

descriptive

Secondary/protocol endpoint/low confidence

Clinicians global impression of change

descriptive

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.