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

This study has been completed.
Information provided by (Responsible Party):
vTv Therapeutics
ClinicalTrials.gov Identifier:
First received: February 28, 2012
Last updated: February 11, 2015
Last verified: February 2015
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of participant plasma TTP4000 concentrations [ Time Frame: Day 0 to Day 84 ] [ Designated as safety issue: No ]

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


Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01548430

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
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 
Study First Received: February 28, 2012
Last Updated: February 11, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2016