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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
TransTech Pharma
ClinicalTrials.gov Identifier:
NCT01548430
First received: February 28, 2012
Last updated: August 29, 2012
Last verified: August 2012
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
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:

U.S. FDA Resources

Further study details as provided by TransTech Pharma:

Primary Outcome Measures:
  • Number of participant with adverse events [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of participant plasma TTP4000 concentrations [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: October 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (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
Genders Eligible for Study:   Both
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
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
TransTech Pharma
Investigators
Study Director: Robert Hernandez, Ph.D. TransTech Pharma, Inc.
  More Information

No publications provided

Responsible Party: TransTech Pharma
ClinicalTrials.gov Identifier: NCT01548430     History of Changes
Other Study ID Numbers: TTP4000-101
Study First Received: February 28, 2012
Last Updated: August 29, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013