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Completed

NCT Number: NCT00130429

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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oxford Project to Investigate Memory and Ageing

Oxford, Oxfordshire, OX3 7JX, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PYM50028

Drug

Primary outcomes

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

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

Secondary outcomes

  1. Mini mental state examination score

  2. Clinical dementia rating (overall and sum of boxes)

  3. CANTAB rapid visual information processing (RVIP) mean latency

  4. CANTAB RVIP total correct hits

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

  6. Clinicians global impression of change

  7. Disability assessment for dementia score

Sponsors and collaborators

Lead sponsor

Phytopharm

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2005
First posted
Aug 15, 2005
Registry last updated
Aug 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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