A randomized, double-blind, placebo-controlled, parallel-group, phase 2 study to evaluate the safety and efficacy of CT1812 in subjects with mild to moderate Alzheimer's disease
- Conditions
- Alzheimer's DiseaseDementia1004225810012272
- Registration Number
- NL-OMON53705
- Lead Sponsor
- Cognition Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 15
1. Men, and women of non-childbearing potential, 50-85 years of age
inclusively, with a
diagnosis of mild to moderate Alzheimer*s disease according to the 2011 NIA-AA
criteria
and at least a 6 month decline in cognitive function documented in the medical
record.
i) Non-childbearing potential for women is defined as postmenopausal (last
natural
menses greater than 24 months) or undergone a documented bilateral tubal
ligation
or hysterectomy. If last natural menses less than 24 months, a serum FSH value
confirming post-menopausal status can be employed.
ii) Male subjects who are sexually active with a woman of child-bearing
potential
must agree to use condoms during the trial and for 3 months after last dose
unless
the woman is using an acceptable means of birth control. Acceptable forms of
birth
control include, birth control pills, or any double combination of:
intrauterine device (IUD), diaphragm, sponge, and cervical cap. Periodic
abstinence, coitus interruptus, exclusive use of spermicides and lactational
amenorrhea method (LAM) are not acceptable contraceptive methods.
2) Diagnostic confirmation by amyloid PET with florbetaben or another approved
amyloid PET
ligand. Previous amyloid imaging study with a positive result will be accepted.
If none is
available, then amyloid PET will be conducted during screening. Diagnostic
confirmation by
a CSF sample collected at the optional screening visit lumbar puncture in place
of amyloid PET will
also be acceptable. Inclusion via CSF samples requires: low Aβ 42
OR low Aβ 42/40 ratio AND either increased total-tau OR increased phospho-tau
based on the ranges established by the central lab.
3) Neuroimaging (MRI, or CT scan due to contraindication of MRI is approved by
Medical Monitor) obtained during screening consistent with the clinical
diagnosis of
Alzheimer*s disease and without findings of significant exclusionary
abnormalities (see
exclusion criteria, number 4). An historical MRI, (or CT scan),up to 1 year
prior to screening, may be
used if there is no history of intervening neurologic disease or clinical
events
(such as a stroke, head trauma etc.) and the subject is without clinical
symptoms or signs
suggestive of such intervening events.
4) MMSE 18-26 inclusive.
5) No active depression and a GDS <=6 (see exclusion criteria number 6).
Subjects with a GDS >6 may be allowed to enroll if the investigator does not
believe the subject is clinically depressed. Investigators must contact the
Medical Monitor to discuss eligibility.
6) Modified Hachinski <=4.
7) Formal education of eight or more years.
8) Participants must have a caregiver/ study partner who in the opinion of the
site principal
investigator, has contact with the study subject for a sufficient number of
hours per week
to provide informative responses on the protocol assessments, oversee the
administration
of study drug, and is willing and able to participate in all clinic visits and
some study
assessments. The caregiver/ study partner must provide written informed consent
to
participate in the study.
9) Participants living at home or in the community (assisted living
acceptable).
10) Ability to swallow CT1812 capsules.
11) Stable pharmacological treatment of any o
1) Hospitalization (except for planned procedures) or change of chronic
concomitant
medication within one month prior to screening.
2) Participants living in a continuous care nursing facility.
3) Contraindications to the MRI examination for any reason. CT scan may be
substituted for an MRI if a subject is unable to tolerate an MRI or an MRI is
contraindicated for medical reasons. The proposed CT scan will be approved by
the Medical Monitor on a case-by-case basis.
4) Screening MRI (or historical MRI, or CT scan due to contraindication of MRI
if approved by medical monitor)) of the brain indicative of significant
abnormality, including, but not limited to, prior hemorrhage or infarct >1 cm3,
>3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular
malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g.
abscess or brain tumor such as meningioma). If a small incidental meningioma is
observed, the Medical Monitor may be contacted to discuss eligibility.
5) Clinical or laboratory findings consistent with:
a) Other primary degenerative, (dementias such as dementia with Lewy bodies,
frontotemporal
dementia, Huntington*s disease, Creutzfeldt-Jakob Disease, Down syndrome,
etc.).
b) Other neurodegenerative condition (Parkinson*s disease, amyotrophic lateral
sclerosis,
etc.).
c) Seizure disorder.
d) Other infectious, metabolic or systemic diseases affecting the central
nervous system
(syphilis, present hypothyroidism, present vitamin B12 or folate deficiency,
other
laboratory values etc.).
6) A current DSM-V diagnosis of active major depression, schizophrenia or
bipolar disorder.
Subjects with depressive symptoms successfully managed by a stable dose of an
antidepressant or antipsychotic would be allowed to enroll
7) Clinically significant, advanced or unstable disease that may interfere with
outcome
evaluations, such as:
a) Chronic liver disease, liver function test abnormalities or other signs of
hepatic
insufficiency (ALT, AST, alkaline phosphatase > 1.5 ULN, lactate dehydrogenase
(LDH)
> 1.5 x ULN).
b) Respiratory insufficiency.
c) Renal insufficiency eGFR < 50 mL/min based on the CKD*EPI formula, as
calculated by
the central laboratory.
d) Heart disease (myocardial infarction, unstable angina, heart failure,
cardiomyopathy
within six months before screening).
e) Bradycardia (<50 beats/min.) or tachycardia (>100 beats/min.). If the heart
rate is below 50 beats/min the subject may be eligible to enroll if the
Investigator has determined that the heart rate < 50 beats/min is stable and
not clinically significant. If the heart rate is above 100 beats/min, the heart
rate assessment may be repeated to assess eligibility.
f) Poorly managed hypertension (systolic >160 mm Hg and/or diastolic >95 mm Hg)
or
hypotension (systolic <90 mm Hg and/or diastolic <60 mm Hg).
g) Uncontrolled diabetes defined by HbA1c >7.5% in participants with diabetes,
Only those
subjects with known diabetes are required to get a HbA1c at screen.
8) History of cancer within 3 years of screening with the exception of fully
excised non-melanoma skin cancers or non-metastatic prostate cancer that has
been stable for at least 6
months.
9) Seropositive for human immunodeficiency virus (HIV). <
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method