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

Phase 2

Completed

• Conditions: Alzheimer's Disease

• Registration Number: NCT00130429
• Lead Sponsor: Phytopharm

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-08-12
• Study First Submitted QC: 2005-08-12
• Study First Posted: 2005-08-15
• Study Completion: 2005-09
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-20
• Last Update Posted: 2009-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Oxford Project to Investigate Memory and Ageing; 🇬🇧 Oxford, Oxfordshire, United Kingdom