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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

vTv Therapeutics

ClinicalTrials.gov Identifier:

NCT01548430

First received: February 28, 2012

Last updated: February 11, 2015

Last verified: February 2015

History of Changes

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:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

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


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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	February 28, 2012
Last Updated:	February 11, 2015

Additional relevant MeSH terms:


Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases	Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders

ClinicalTrials.gov processed this record on September 21, 2017

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