A Safety and Tolerability Evaluation of Two 10-Week Dose Regimens of Orally-Administered PF-04494700 in Alzheimer's Patients

Pfizer

Status and phase: Completed; Phase 2

Conditions: Alzheimer Disease

Treatments: Drug: PF-04494700 - Low Dose Arm; Drug: Placebo Comparator; Drug: PF-04494700 - High Dose Arm

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00141661

B0341008

TTP488-201

Details and patient eligibility

About

A 10-week safety and tolerability study of a potential treatment for mild to moderate Alzheimer's disease.

Enrollment: 67 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of probably Alzheimer's disease for at least 1 year.
• Mini Mental State Exam (MMSE) score between 12-26 at screening.
• Participants must be receiving a cholinesterase inhibitor and/or memantine for at least 4 months, and on a stable dose for at least 2 months.

Exclusion criteria

• Current evidence of a neurological or psychiatric illness that could contribute to dementia.
• Living alone.
• Poorly controlled high blood pressure.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

67 participants in 3 patient groups, including a placebo group

Low Dose Arm

Experimental group

Treatment:

Drug: PF-04494700 - Low Dose Arm

High Dose Arm

Experimental group

Treatment:

Drug: PF-04494700 - High Dose Arm

Placebo Control

Placebo Comparator group

Treatment:

Drug: Placebo Comparator