NCT00021723

Brief Summary

A multi-center, double-blind, placebo-controlled out-patient, safety, tolerability, and pilot efficacy study of intramuscular AN-1792 in patients with mild to moderate Alzheimer's disease.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
375

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2001

Geographic Reach
1 country

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2001

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2001

Completed
26 days until next milestone

Study Start

First participant enrolled

September 1, 2001

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
Last Updated

September 24, 2009

Status Verified

November 1, 2001

First QC Date

August 2, 2001

Last Update Submit

September 22, 2009

Conditions

Keywords

Alzheimer'sAN-1792AIP-001

Interventions

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Mild to moderate Alzheimer's disease. Ability to cooperate with MRI scanning and neuropsychological testing. Live at home or in the community and a caregiver capable of accompanying the patient on all clinic visits and visiting the patient at least 5 times per week.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (11)

Pivotal Research Centers

Peoria, Arizona, 85381, United States

Location

21st Century Neurology

Phoenix, Arizona, 85013, United States

Location

California Clinical Trials

Beverly Hills, California, 90211, United States

Location

UCSD Medical Center

La Jolla, California, 92093, United States

Location

Pharmacology Research Institute

Northridge, California, 91324-4625, United States

Location

Baumel-Eisner Neuromedical Institute

Bay Harbor Islands, Florida, 33154, United States

Location

Baumel-Eisner Neuromedical Institute

Boca Raton, Florida, 33486, United States

Location

Baumel-Eisner Neuromedical Institute

Fort Lauderdale, Florida, 33321, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Clinical Pharmaceutical Trials, Inc.

Tulsa, Oklahoma, 74104, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 2, 2001

First Posted

August 6, 2001

Study Start

September 1, 2001

Study Completion

September 1, 2003

Last Updated

September 24, 2009

Record last verified: 2001-11

Locations