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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00890890

Enrollment

263

Registered

2009-04-30

Start date

2009-05-31

Completion date

2013-07-31

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Brief summary

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. In addition patients will be seen for safety visits at 4 and 12 weeks post treatment.

Interventions

DRUGAvagacestat

Capsules, Oral, 50 mg, once daily, 104 - 220 Weeks

DRUGPlacebo

Capsules, Oral, 0 mg, once daily, 104 - 220 Weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

45 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Patient meets clinical criteria for prodromal Alzheimer's disease (MMSE 24-30) * Memory complaint by subject or study partner * CSF aβ42 levels \< 200pg/mL or Total Tau/aβ42 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 capsules

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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings	Every 12 weeks up to week 220

Secondary

Measure	Time frame
Predictive value of Cerebral Spinal Fluid (CSF) biomarkers (Aβ40, and Aβ42, total Tau, total Tau/Aβ42 ratio, phosphorylated Tau) on progression to dementia	Baseline (Week 0), Week 2 (optional), Week 24 and Week 104

Countries

Canada, Denmark, Finland, France, Sweden, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026