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Trial record 1 of 1 for:    NCT01548430
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A Safety Study of TTP4000 in Subjects With Alzheimer's Disease

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. Identifier: NCT01548430
Recruitment Status : Completed
First Posted : March 8, 2012
Last Update Posted : February 12, 2015
Information provided by (Responsible Party):
vTv Therapeutics

Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer's Disease Drug: TTP4000 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
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
Study Start Date : October 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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 identifier (NCT number): NCT01548430

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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
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Study Director: Robert Hernandez, Ph.D. TransTech Pharma, Inc.
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Responsible Party: vTv Therapeutics Identifier: NCT01548430    
Other Study ID Numbers: TTP4000-101
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: February 12, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders