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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00130429
• Other study ID #: P58/09ME/03/04
• Status: Completed
• Phase: Phase 2
• First received: August 12, 2005
• Last updated: August 20, 2009
• Start date: January 2004
• Est. completion date: September 2005

Study information

• Verified date: August 2009
• Source: Phytopharm
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• PYM50028

Locations

Country	Name	City	State
United Kingdom	Oxford Project to Investigate Memory and Ageing	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
Phytopharm

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hopkins verbal learning test (revised) total word recall after 12 weeks
Primary	Cambridge neuropsychological test automated battery (CANTAB) paired associate learning (Phytopharm modified form) total adjusted error score after 12 weeks
Secondary	Mini mental state examination score
Secondary	Clinical dementia rating (overall and sum of boxes)
Secondary	CANTAB rapid visual information processing (RVIP) mean latency
Secondary	CANTAB RVIP total correct hits
Secondary	CANTAB spatial working memory within error, between error and strategy scores
Secondary	Clinicians global impression of change
Secondary	Disability assessment for dementia score