NCT01421056

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of ascending oral doses of CHF 5074 after prolonged administration to patients with mild cognitive impairment.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_2

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 22, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

February 6, 2014

Status Verified

January 1, 2014

Enrollment Period

1.3 years

First QC Date

August 5, 2011

Last Update Submit

January 7, 2014

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Determine maximum tolerated dose of CHF 5074 after multiple oral once daily administration to patients with mild cognitive impairment

    24 weeks

Study Arms (3)

CHF 5074 1x

EXPERIMENTAL

oral tablet, multidose

Drug: CHF 5074 1x

CHF 5074 2x

EXPERIMENTAL

oral tablet, multidose

Drug: CHF 5074 2x

CHF 5074 3x

EXPERIMENTAL

oral tablet, multidose

Drug: CHF 5074 3x

Interventions

CHF 5074 1xDRUG

oral tablet, 1x, once a day in the morning for 24 weeks

CHF 5074 1x
CHF 5074 2xDRUG

oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 20 weeks

CHF 5074 2x
CHF 5074 3xDRUG

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 16 weeks

CHF 5074 3x

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of amnestic or non-amnestic Mild Cognitive Impairment.
  • Mini-Mental State Examination score higher than 24 at screening.
  • MRI scan of the brain at screening with fluid-attenuation inversion recovery (FLAIR) and T2\*-weighted gradient-recalled-echo (GRE) sequences.

You may not qualify if:

  • Diagnosis of Alzheimer's disease according to the (DSM-IV-TR) or NINCDS-ADRDA criteria.
  • Any medical condition that could explain the patients cognitive deficits.
  • CT or MRI brain imaging results obtained within 12 months prior to baseline showing evidence of infection, infarction, or focal lesions of clinical significance
  • MRI scan at screening showing more than 4 cerebral microhemorrhages (lesions with diameter ≤ 10 mm).
  • Geriatric Depression Scale (30-point scale) score \> 9 at screening.
  • History of stroke.
  • Modified Hachinski ischemic scale score \> 4 at screening.
  • Women of childbearing potential.
  • Vitamin B12 or folate deficiency.
  • Diagnosis of schizophrenia or recurrent mood disorder (including unipolar and bipolar disorders) within 3 years of screening.
  • Current diagnosis of peptic ulcer or gastrointestinal bleeding within the last year and/or chronic inflammatory bowel disease.
  • Concomitant use of donepezil at doses \> 5 mg/day or other cholinesterase inhibitors (rivastigmine or galantamine) at any dose.
  • Concomitant use of memantine at dose \> 20 mg/day.
  • Concomitant use of psychoactive drugs (sedatives, hypnotics, etc).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Memory Enhancement Center of America, Inc.

Eatontown, New Jersey, 07724, United States

Location

Memory Center of New Jersey, Inc.

Monroe Twp, New Jersey, 08831, United States

Location

Memory Enhancement Center of NJ, Inc.

Toms River, New Jersey, 08755, United States

Location

Senior Adults Specialty Research

Austin, Texas, 78757, United States

Location

Clinica Santa Maria, Div Neurologia

Castellanza, Italy

Location

Osp. Niguarda Ca'Granda, Dip. Di Neuroscienze

Milan, Italy

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Joel S. Ross, MD

    Memory Enhancement Center of America, Inc.

    PRINCIPAL INVESTIGATOR

  • Gabriella Bottini, Prof.

    Osp. Niguarda Ca Granda

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2011

First Posted

August 22, 2011

Study Start

July 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

February 6, 2014

Record last verified: 2014-01

Locations

US(4)IT(2)