Skip to main content
OpenTrials
Completed

NCT Number: NCT01548430

A Safety Study of TTP4000 in Subjects With Alzheimer's Disease

The purpose of the study is to examine the safety, tolerability, immunogenicity and pharmacokinetics of TTP4000 in subjects with Alzheimer's disease with mild cognitive impairment.

Completed

Looking for future studies?

Notify Me

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–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males or females ≥ 50 years of age.
  • Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive.
  • Weight ≥ 50 kg.
  • Alzheimer's disease according to the DSM-IV-TR criteria and a score between 20 and 26 on the Mini Mental State Exam.
  • Subject must have a medical history for at least 6 months prior to Screening (confirmed by medical records) of a diagnosis of mild Alzheimer's disease.

Exclusion criteria

  • Current evidence or history within the last 3 years of a neurological or psychiatric illness that could contribute to dementia, including, but not limited to: epilepsy, focal brain lesion, Parkinson's disease, seizure disorder, or head injury with loss of consciousness; DSM-IV-TR criteria for any major psychiatric disorder, including psychosis, major depression, and bipolar disorder.
  • Participation and dosing in another clinical trial, involving any marketed or investigational drug, within 30 days before Screening Visit.

Treatment and study plan

TTP4000

Drug

Placebo

Drug

Primary outcomes

  1. Number of participant with adverse events

    Time frame: Day 0 to Day 84

Secondary outcomes

  1. Evaluation of participant plasma TTP4000 concentrations

    Time frame: Day 0 to Day 84

Sponsors and collaborators

Lead sponsor

vTv Therapeutics

Industry

Registry information

Official study title

A Double-blind, Randomized, Placebo-controlled, Phase 1 Study of 2 Escalating, Single Subcutaneous Doses to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of TTP4000 in Subjects With Alzheimer's Disease With Mild Cognitive Impairment

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 8, 2012
Registry last updated
Feb 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.