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Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074

NCT01303744 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2016-01-11

Study results available
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Summary

To evaluate the safety and tolerability of ascending oral doses of CHF 5074 administered once per day for up to 12 weeks to patients with mild cognitive impairment.

Conditions

Interventions

DRUG

CHF 5074 1x

oral tablet, 1x, once a day in the morning for 12 weeks

DRUG

CHF 5074 2x

oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks

DRUG

CHF 5074 3x

oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks

DRUG

Placebo

oral tablet, once a day in the morning for 12 weeks

Sponsors & Collaborators

  • CERESPIR

    lead INDUSTRY

Principal Investigators

  • Joel S. Ross, MD · Memory Enhancement Center of America, Inc.

  • Gabriella Bottini, Prof. · Osp. Niguarda Ca Granda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States
  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01303744 on ClinicalTrials.gov