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Completed

NCT Number: NCT00810147

A Phase II, Multicenter, Double Blind, Placebo-Controlled Safety, Tolerability Study of BMS-708163 in Patients With Mild to Moderate Alzheimer's Disease

The purpose of this study is to determine the safety and tolerability of BMS-708163 in patients with mild to moderate Alzheimer's disease over a treatment period of 12-weeks and the course of any potential effects during a 12-week wash-out period

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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–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Odense, Denmark

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of Mild to Moderate Alzheimer's disease (MMSE 16-26)
  • 6 Month cognitive decline
  • Stable marketed AD therapy x2 months or additional marketed AD therapy during study
  • Score of <=4 on the Modified Hachinski Ischemia Scale
  • CT results consistent with Alzheimer's disease
  • Medically stable
  • 6 years education
  • Reliable study partner (caregiver)
  • Must be able to swallow capsules

Exclusion criteria

  • Premenopausal women
  • Dementia due to other causes than Alzheimer's disease
  • History of stroke
  • Immunocompromised
  • Active peptic ulcer, GI bleed, chronic inflammatory bowel disease, chronic diarrhea or past GI surgery that would impact drug absorption
  • Unstable Vitamin B-12 deficiency
  • Hematologic or solid malignancy within 5 years
  • Geriatric Depression Scale >= 6
  • Unstable medical condition
  • Alcohol or drug abuse history with 12-months of study entry
  • Significant drug allergy
  • Alzheimer's disease modification experimental therapy with 12 months of study entry
  • Prisoners, compulsory psychiatric patients, or residents of nursing home or skilled nursing facility at entry
  • Any other experimental therapy with 30-days of study entry

Treatment and study plan

BMS-708163

Drug

Capsules, Oral, 25 mg, once daily, 24 weeks

Placebo

Drug

Capsules, Oral, 0 mg, once daily, 24 weeks

Primary outcomes

  1. Adverse Events

    Time frame: Weekly for the first 12-weeks of the 24-Week dosing period (Baseline-Week-12) and every 2 weeks during the second 12-weeks of the 24-Week dosing period (Weeks 14-24) and during the subsequent 12-week washout period (Weeks 28, 32, & 36)

Secondary outcomes

  1. Pharmacodynamics effects of Cerebral Spinal Fluid

    Time frame: Baseline, Week 12 and Week 24

  2. Pharmacodynamics effects of the Alzheimer's Disease Assessment Scale - Cognitive Subscale

    Time frame: Baseline, Week 12, Week 24 and Week 36

  3. Pharmacodynamics effects of the Alzheimer's Disease Collaborative Study - Activities of Daily Living scale

    Time frame: Baseline, Week 12, Week 24 and Week 36

  4. Pharmacodynamics effects of the Global clinical impression as assessed with the Clinical Dementia Rating-Sum of Boxes

    Time frame: Baseline, Week 12, Week 24 and Week 36

  5. Characterize Pharmacodynamics/Pharmacokinetics effects of the plasma exposure of BMS-708163 and variability in a population with Alzheimer's disease

    Time frame: Baseline, Week 12 and Week 24

  6. Characterize Pharmacodynamics/Pharmacokinetics effects in refining the Pharmacokinetics/Pharmacodynamics model with Phase 2 data

    Time frame: Baseline, Week 12 and Week 24

  7. Characterize Pharmacodynamics/Pharmacokinetics effects by exploring correlations between exposure, biomarkers, and clinical effects

    Time frame: Baseline, Week 12 and Week 24

  8. Characterize Pharmacodynamics/Pharmacokinetics effects by exploring Pharmacokinetics variability, including the correlation between polymorphisms of CYP enzymes

    Time frame: Baseline, Week 12 and Week 24

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of BMS-708163 in the Treatment of Patients With Mild to Moderate Alzheimer's Disease

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 17, 2008
Registry last updated
Oct 12, 2015

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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