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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00130429

Enrollment

250

Registered

2005-08-15

Start date

2004-01-31

Completion date

2005-09-30

Last updated

2009-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

dementia, memory, Hopkins verbal learning test, paired associated learning

Brief summary

The purpose of this study is to assess the effect of PYM50028 administered once daily for up to 12 weeks on the memory and other faculties of subjects with dementia due to Alzheimer's disease.

Interventions

DRUGPYM50028

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Hopkins verbal learning test (revised) total word recall after 12 weeks	—
Cambridge neuropsychological test automated battery (CANTAB) paired associate learning (Phytopharm modified form) total adjusted error score after 12 weeks	—

Secondary

Measure	Time frame
Clinical dementia rating (overall and sum of boxes)	—
CANTAB rapid visual information processing (RVIP) mean latency	—
Mini mental state examination score	—
Clinicians global impression of change	—
Disability assessment for dementia score	—
CANTAB spatial working memory within error, between error and strategy scores	—
CANTAB RVIP total correct hits	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026