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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01548430
First Posted: March 8, 2012
Last Update Posted: February 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
vTv Therapeutics
February 28, 2012
March 8, 2012
February 12, 2015
October 2011
February 2013   (Final data collection date for primary outcome measure)
Number of participant with adverse events [ Time Frame: Day 0 to Day 84 ]
Number of participant with adverse events
Complete list of historical versions of study NCT01548430 on ClinicalTrials.gov Archive Site
Evaluation of participant plasma TTP4000 concentrations [ Time Frame: Day 0 to Day 84 ]
Evaluation of participant plasma TTP4000 concentrations
Not Provided
Not Provided
 
A Safety Study of TTP4000 in Subjects With Alzheimer's Disease
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Alzheimer's Disease
  • Drug: TTP4000
  • Drug: Placebo
  • Experimental: TTP4000 1.0 mg/kg
    Administered subcutaneously
    Intervention: Drug: TTP4000
  • Experimental: TTP4000 3.0 mg/kg
    Administered subcutaneously
    Intervention: Drug: TTP4000
  • Placebo Comparator: Placebo
    Administered subcutaneously
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
February 2013
February 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01548430
TTP4000-101
No
Not Provided
Not Provided
vTv Therapeutics
vTv Therapeutics
Not Provided
Study Director: Robert Hernandez, Ph.D. TransTech Pharma, Inc.
vTv Therapeutics
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP