We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
  Purpose
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.

Condition Intervention Phase
Alzheimer's Disease Drug: TTP4000 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Official 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

Resource links provided by NLM:


Further study details as provided by vTv Therapeutics:

Primary Outcome Measures:
  • Number of participant with adverse events [ Time Frame: Day 0 to Day 84 ]

Secondary Outcome Measures:
  • Evaluation of participant plasma TTP4000 concentrations [ Time Frame: Day 0 to Day 84 ]

Enrollment: 8
Study Start Date: October 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TTP4000 1.0 mg/kg
Administered subcutaneously
Drug: TTP4000
Experimental: TTP4000 3.0 mg/kg
Administered subcutaneously
Drug: TTP4000
Placebo Comparator: Placebo
Administered subcutaneously
Drug: Placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548430


Locations
United States, Florida
Miami, Florida, United States
United States, North Carolina
Durham, North Carolina, United States
High Point, North Carolina, United States
Sponsors and Collaborators
vTv Therapeutics
Investigators
Study Director: Robert Hernandez, Ph.D. TransTech Pharma, Inc.
  More Information

Responsible Party: vTv Therapeutics
ClinicalTrials.gov Identifier: NCT01548430     History of Changes
Other Study ID Numbers: TTP4000-101
First Submitted: February 28, 2012
First Posted: March 8, 2012
Last Update Posted: February 12, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders