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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TTP4000 1.0 mg/kg

Administered subcutaneously

Group Type EXPERIMENTAL

TTP4000

Intervention Type DRUG

TTP4000 3.0 mg/kg

Administered subcutaneously

Group Type EXPERIMENTAL

TTP4000

Intervention Type DRUG

Placebo

Administered subcutaneously

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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TTP4000

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No