CompletedNCT01303744CT04Updated Jan 11, 2016Results posted

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

A Phase 2 interventional study of CHF 5074 1x and CHF 5074 2x in Alzheimer's Disease, sponsored by CERESPIR. Completed at 9 sites in 2 countries. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2016-01-11.

Sponsored by CERESPIR · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 96
Allocation: Randomized
Ages: 18 Years to 79 Years
Sex: All

Study 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 studied

Alzheimer's Disease

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Alzheimer Disease 3,678

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 96 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

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Lead sponsor

CERESPIR is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 79 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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).

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 96 participants (actual)

Study arms

Experimental
CHF 5074 1x
oral tablet, multidose
Drug: CHF 5074 1x
Experimental
CHF 5074 2x
oral tablet, multidose
Drug: CHF 5074 2x
Experimental
CHF 5074 3x
oral tablet, multidose
Drug: CHF 5074 3x
Placebo comparator
Placebo
placebo, oral tablet, multidose
Drug: Placebo

Interventions

DrugCHF 5074 1x
oral tablet, 1x, once a day in the morning for 12 weeks
DrugCHF 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
DrugCHF 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
DrugPlacebo
oral tablet, once a day in the morning for 12 weeks

What researchers measure

Primary outcomes

Differences in ∆sCD40L Levels Between CHF 5074 Doses and Placebo at Any Specific Time Point
To assess if there were differences in ΔsCD40L levels between CHF 5074 doses and placebo
Time frame: up to 12 weeks

Secondary outcomes

Measurement of Trough CHF 5074 Plasma Levels
evaluate the pharmacokinetics (PK) of CHF 5074 in patients with MCI.
Time frame: Days 85
Changes in Plasma ΔTNFα Concentrations
Time frame: 29 days

Results

Posted Jan 11, 2016

Participant flow

Participant flow — Overall Study
Milestone	CHF 5074 1x	CHF 5074 2x	CHF 5074 3x	Placebo
Started	24	24	24	24
Completed	24	24	24	24
Not completed	0	0	0	0

Outcome measures

PrimaryDifferences in ∆sCD40L Levels Between CHF 5074 Doses and Placebo at Any Specific Time Point

To assess if there were differences in ΔsCD40L levels between CHF 5074 doses and placebo

Time frame:: up to 12 weeks
Reported as:: Mean · pg/ml

Differences in ∆sCD40L Levels Between CHF 5074 Doses and Placebo at Any Specific Time Point
pg/ml	CHF 5074 1x	CHF 5074 2x	CHF 5074 3x	Placebo
Differences in ∆sCD40L Levels Between CHF 5074 Doses and Placebo at Any Specific Time Point	270.28 ± 371.09	403.22 ± 377.79	-1293.42 ± 362.69	242.49 ± 361.32

SecondaryMeasurement of Trough CHF 5074 Plasma Levels

evaluate the pharmacokinetics (PK) of CHF 5074 in patients with MCI.

Time frame:: Days 85
Reported as:: Mean · ng/ml

Measurement of Trough CHF 5074 Plasma Levels
ng/ml	CHF 5074 1x	CHF 5074 2x	CHF 5074 3x	Placebo
Measurement of Trough CHF 5074 Plasma Levels	5497 ± 4940	7882 ± 8231	19999 ± 17474	—

SecondaryChanges in Plasma ΔTNFα Concentrations

Time frame:: 29 days
Reported as:: Mean · pg/ml

Changes in Plasma ΔTNFα Concentrations
pg/ml	CHF 5074 1x	CHF 5074 2x	CHF 5074 3x	Placebo
Changes in Plasma ΔTNFα Concentrations	2.57 ± 1.1	-0.339 ± 1.09	-1.568 ± 1.05	0.039 ± 1.05

Adverse events

Collected over Trial duration. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
CHF 5074 1x	—	2/24 (8.3%)	9/24 (37.5%)
CHF 5074 2x	—	2/24 (8.3%)	18/24 (75%)
CHF 5074 3x	—	1/24 (4.2%)	11/24 (45.8%)
Placebo	—	1/24 (4.2%)	7/24 (29.2%)

Most frequent serious events

Most frequent serious events
Event	CHF 5074 1x	CHF 5074 2x	CHF 5074 3x	Placebo
intestinal obstructionGastrointestinal disorders	0/24	0/24	0/24	1/24
Acute congestive heart failureCardiac disorders	0/24	0/24	1/24	0/24
cardiac failure congestiveCardiac disorders	1/24	0/24	0/24	0/24
bronchitisRespiratory, thoracic and mediastinal disorders	1/24	0/24	0/24	0/24
cerebrovascular accidentCardiac disorders	1/24	0/24	0/24	0/24
penis carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/24	0/24	1/24	0/24
femur fractureMusculoskeletal and connective tissue disorders	0/24	1/24	0/24	0/24
adenocarcinoma f transverse colonNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/24	1/24	0/24	0/24

Most frequent other events

Most frequent other events
Event	CHF 5074 1x	CHF 5074 2x	CHF 5074 3x	Placebo
diarrhoeaGastrointestinal disorders	2/24	3/24	5/24	2/24
nauseaGastrointestinal disorders	1/24	4/24	0/24	0/24
back painMetabolism and nutrition disorders	1/24	3/24	2/24	1/24
DizzinessNervous system disorders	1/24	2/24	3/24	1/24
Urinary tract infectionInfections and infestations	3/24	0/24	0/24	1/24
headacheGeneral disorders	1/24	2/24	0/24	2/24
vomitingGastrointestinal disorders	0/24	2/24	1/24	0/24
nasopharyngitisRespiratory, thoracic and mediastinal disorders	0/24	2/24	0/24	0/24

Baseline characteristics

Age, Continuous
Age, Continuous(years)	CHF 5074 1x	CHF 5074 2x	CHF 5074 3x	Placebo	Total
Mean	67.7 ± 8.1	68.9 ± 8.5	69.0 ± 9.2	68.1 ± 8.0	68.4 ± 8.3

Sex: Female, Male
Sex: Female, Male(Participants)	CHF 5074 1x	CHF 5074 2x	CHF 5074 3x	Placebo	Total
Female	10	11	11	8	40
Male	14	13	13	16	56

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	CHF 5074 1x	CHF 5074 2x	CHF 5074 3x	Placebo	Total
American Indian or Alaska Native	0	0	0	0	0
Asian	0	1	0	1	2
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	1	1	0	0	2
White	23	22	24	23	92
More than one race	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	CHF 5074 1x	CHF 5074 2x	CHF 5074 3x	Placebo	Total
United States	24	24	19	24	91
Italy	0	0	5	0	5

Study locations

9 sites

Comprehensive NeuroScience, Inc.
St. Petersburg, Florida 33716, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey 07724, United States
Memory Center of New Jersey, Inc.
Monroe Twp, New Jersey 08831, United States
Memory Enhancement Center of NJ, Inc.
Toms River, New Jersey 08755, United States
Senior Adults Specialty Research
Austin, Texas 78757, United States
Clinica Santa Maria, Div Neurologia
Castellanza, Italy
Osp. Maggiore Policlinico, Clin. Neurol
Milano, Italy
Osp. Niguarda Ca'Granda, Dip. Di Neuroscienze
Milano, Italy
Nuovo Osp Civ S. Agostino Estense, Dip di Neuroscienze
Modena, Italy

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01303744
Lead sponsor: CERESPIR
Responsible party: Sponsor
First posted: Feb 25, 2011
Start date: Mar 2011
Primary completion: Apr 2012
Completion: Apr 2012
Results posted: Jan 11, 2016
Last update: Jan 11, 2016

Study contacts

Joel S. Ross, MD

principal investigator · Memory Enhancement Center of America, Inc.

Gabriella Bottini, Prof.

principal investigator · Osp. Niguarda Ca Granda

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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