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

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

Study Description
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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

Study Design
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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

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Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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
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
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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
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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
Investigators
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Study Director: Robert Hernandez, Ph.D. TransTech Pharma, Inc.
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: vTv Therapeutics
ClinicalTrials.gov 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
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders