A Multicenter, Double Blind, Placebo-Controlled, Safety and Tolerability Study of BMS-708163 in Patients With Prodromal Alzheimer's Disease

Condition: Alzheimer's Disease

What is the purpose of this trial?

The purpose of this study is to determine the safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease over a treatment period of a minimum of 104-weeks

Dates: May 2009 -
Study Status: Recruiting

Who can participate?

Ages Eligible: 45 Years - 90 Years
Gender Eligible: Both

Inclusion Criteria:

- Patient meets clinical criteria for prodromal Alzheimer's disease (MMSE 24-30)

- Memory complaint by subject or study partner

- CSF a242 levels < 200pg/mL or Total Tau/a242 ratio of = 0.39

- Score of =4 on the Modified Hachinski Ischemia Scale

- CT results consistent with Alzheimer's disease

- Medically stable

- 6 years education

- Reliable study partner

- Must be able to swallow tablets

Exclusion Criteria:

- Premenopausal women

- DSM-IV diagnosis of Dementia 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

- 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

Sponsor: Bristol-Myers Squibb
Phase: Phase 2

First Received: April 29, 2009
Last Updated: August 30, 2010
Clinicaltrials.gov ID: NCT00890890
Study HIC # 0904004964

Condition: Alzheimer's Disease

Interventions: Drug: BMS-708163;
Drug: Placebo

What is the purpose of this trial?

The purpose of this study is to determine the safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease over a treatment period of a minimum of 104-weeks

Dates: May 2009 -
Study Status: Recruiting

Who can participate?

Ages Eligible: 45 Years - 90 Years
Gender Eligible: Both

Inclusion Criteria:

- Patient meets clinical criteria for prodromal Alzheimer's disease (MMSE 24-30)

- Memory complaint by subject or study partner

- CSF aß42 levels < 200pg/mL or Total Tau/aß42 ratio of = 0.39

- Score of =4 on the Modified Hachinski Ischemia Scale

- CT results consistent with Alzheimer's disease

- Medically stable

- 6 years education

- Reliable study partner

- Must be able to swallow tablets

Exclusion Criteria:

- Premenopausal women

- DSM-IV diagnosis of Dementia 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

- 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