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



Status:Completed
Conditions:Alzheimer Disease, Cognitive Studies
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 79
Updated:4/21/2016
Start Date:March 2011
End Date:April 2012

Use our guide to learn which trials are right for you!

A Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Tolerability of Multiple Dose Regimens of CHF 5074 and to Explore the Effects in Patients With Mild Cognitive Impairment

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.


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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).
We found this trial at
6
sites
Eatontown, New Jersey 07724
?
mi
from
Eatontown, NJ
Click here to add this to my saved trials
Austin, Texas 78757
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Castellanza,
Click here to add this to my saved trials
Monroe Twp, New Jersey 08831
?
mi
from
Monroe Twp, NJ
Click here to add this to my saved trials
St. Petersburg, Florida 33716
?
mi
from
St. Petersburg, FL
Click here to add this to my saved trials
Toms River, New Jersey 08755
?
mi
from
Toms River, NJ
Click here to add this to my saved trials