Search Results
within category "Brain & Neurological"
Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
The LUCINDA Trial: LeUprolide Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's (LUCINDA)
The LUCINDA Trial is a three-site, phase II, randomized, double-blind, placebo-controlled
study of leuprolide acetate (Eligard) in women with Mild Cognitive Impairment or Alzheimer's
Disease taking a stable dose of a cholinesterase inhibitor medication like donepezil. Its
objective is to assess the efficacy of a 48-week regimen of leuprolide (22.5 mg per 12 weeks)
compared to placebo on cognitive function, global function and plasma and neuroimaging
biomarkers.
Craig Atwood
Female
60 Years to 120 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03649724
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Inclusion Criteria:
• Female, post-menopausal
• Probable AD or MCI due to AD according to NIA-AA criteria
• Taking a stable dose of a cholinesterase inhibitor such as donepezil/Aricept and
dosage likely to remain stable throughout the trial
• MOCA > 11 or blind MOCA > 8 (inclusive) at screening visit
• Hachinski score <5 supporting clinical judgment that dementia is not of vascular
origin
• Fluent in English
• has a study partner / caregiver who interacts with the subject for at least 5 hours
per week on average and can participate in evaluations
Exclusion Criteria:
• Presence based on exam, history or MRI of significant brain disease other than AD such
as schizophrenia, epilepsy, Parkinson's disease or large territory stroke
• Current substance abuse in accord with DSM V criteria
• Significantly depressed (Geriatric Depression Scale > 10)
• Physical or psychological MRI contraindications, or likely unable to tolerate
neuroimaging
• Taking other medications known to affect serum sex hormone or gonadotropin
concentrations such as estrogen and/or progesterone for hormone replacement therapy,
goserelin or danazol
• Presence of significant systemic illness likely to interfere with participation in or
completion of the study or to affect study results such as cancer within 5 years
(other than non-melanoma skin cancer), autoimmune disease, recent myocardial
infarction, signs/symptoms of organ failure based on history, ECG, screening
laboratory and/or physical exams
• Receiving other investigational drugs within 30 days or 5 half-lives prior to
randomization, whichever is longer
AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid
The primary purpose of this study is to determine whether treatment with lecanemab is
superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite
5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with
lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by
amyloid positron emission tomography (PET) at 216 weeks of treatment (A3 Trial). This study
will also evaluate the long-term safety and tolerability of lecanemab in participants
enrolled in the Extension Phase.
Cynthia Carlsson, MD
All
55 Years to 80 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04468659
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Inclusion criteria:
Participants must meet all of the following criteria to be included in this study:
1. Male or female, age 55 to 80 years inclusive at the time of informed consent, with a
plasma biomarker result that is predictive of intermediate or elevated brain amyloid
at Screening or known before Screening to have elevated or intermediate amyloid
according to previous PET, cerebrospinal fluid (CSF), or plasma testing
• Those 55 to 64 must have 1 of the following additional risk factors, given the
relatively low rates of amyloid positivity less than (<) 65 years, before screening:
• First degree relative diagnosed with dementia onset before age 75, or
• Known to possess at least 1 apolipoprotein E4 variant (APOE4) allele, or
• Known before screening to have elevated brain amyloid according to previous
plasma biomarker results, PET imaging, or CSF testing
2. Global Clinical Dementia Rating (CDR) score of 0 at screening
3. Mini Mental State Examination score greater than or equal to (>=) 27 (with educational
adjustments) at screening.
4. Wechsler Memory Scale-Revised Logical Memory subscale II (WMS-R LM II) score at
screening of >=6
5. A45 Trial: Elevated brain amyloid pathology by amyloid PET: defined as approximately
greater than (>) 40 Centiloids on screening scan A3 Trial: Intermediate levels of
brain amyloid pathology by amyloid PET: defined as approximately 20 to 40 Centiloids
on screening scan
6. Has a study partner that is willing to participate as a source of information and has
approximately weekly contact with the participant (contact can be in-person, via
telephone or electronic communication). The study partner must have sufficient contact
such that the investigator feels the study partner can provide meaningful information
about the participant's daily function
7. Provide written (or electronic, if allowed per country-specific regulations) informed
consent
8. Willing and able to comply with all aspects of the protocol
For extension phase :
1. Completed the Core Study, or meet the following progression criteria during the Core
Study:
• Two consecutive CDR visits with Global Scores > zero when measured at least 6
months apart within the Core Study
• The principal investigator's confirmation that the participant has clinically
declined consistent progression to EAD
2. Must continue to have a study partner who is willing and able to provide follow-up
information on the participant throughout the course of the Extension Phase. The study
partner must provide separate written informed consent for the Extension Phase. Study
partners must continue to have sufficient contact such that the investigator feels the
study partner can provide meaningful information about the participant's daily
functions
3. Provide written informed consent for the Extension Phase. If a participant lacks
capacity to consent in the investigator's opinion, the participant's assent should be
obtained, if required and in accordance with local laws, regulations, and customs,
plus the written informed consent of a legal representative (capacity to consent and
the definition of a legal representative should be determined in accordance with
applicable local laws and regulations). In countries where local laws, regulations,
and customs do not permit participants who lack capacity to consent to participate in
this study (example, Spain), they will not be enrolled
4. Willing and able to comply with all aspects of the protocol
Exclusion criteria:
Participants who meet any of the following criteria will be excluded from this study:
1. Females who are breastfeeding or pregnant at screening or baseline
2. Females of childbearing potential who:
• Within 28 days before study entry, did not use a highly effective method of
contraception For sites outside of Europe, it is permissible that if a highly
effective method of contraception is not appropriate or acceptable to the participant,
then the participant must agree to use a medically acceptable method of contraception
3. History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of
screening
4. Current or history within the past 2 years of psychiatric diagnosis or symptoms that,
in the opinion of the investigator, could interfere with study procedures
5. Contraindications to 3 Tesla magnetic resonance imaging (MRI) scanning, including
cardiac pacemaker/defibrillator, ferromagnetic metal implants (example, in-skull and
cardiac devices other than those approved as safe for use in MRI scanners), or exhibit
other significant pathological findings on brain MRI at Screening
6. Hypersensitivity to any monoclonal antibody treatment
7. Any immunological disease which is not adequately controlled, or which requires
treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives of
monoclonal antibodies), systemic immunosuppressants, or plasmapheresis during the
study
8. Bleeding disorder that is not under adequate control (including a platelet count
<50,000 or international normalized ratio [INR] >1.5) at screening
9. Results of laboratory tests conducted during screening that are outside the following
limits:
• Thyroid stimulating hormone (TSH) above normal range
• Abnormally low (below lower limit of normal [LLN]) serum vitamin B12 levels for
the testing laboratory (if participant is taking vitamin B12 injections, level
should be at or above the LLN for the testing laboratory). A low vitamin B12 is
exclusionary, unless the required follow-up labs (homocysteine and methylmalonic
acid [MMA]) indicate that it is not physiologically significant
10. Known to be human immunodeficiency virus (HIV) positive
11. Any other clinically significant abnormalities that in the opinion of the investigator
require further investigation or treatment or may interfere with study procedures or
safety
12. Malignant neoplasms within 3 years of screening (except for basal or squamous cell
carcinoma in situ of the skin, or localized prostate cancer in male participants with
treatment cycles completed at least 6 months before screening). Participants who had
malignant neoplasms but who have had at least 3 years of documented uninterrupted
remission before screening need not be excluded
13. Answer "yes" to Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation Type
4 or 5, or any suicidal behavior assessment within 6 months before screening, at
screening, or at baseline, or has been hospitalized or treated for suicidal behavior
in the past 5 years before screening
14. Known or suspected history of drug or alcohol abuse or dependence within 2 years
before screening or a positive urine drug test at screening. Participants who test
positive for benzodiazepines, opioids, or tetrahydrocannabinol (THC) in urine drug
testing need not be excluded unless in the clinical opinion of the investigator this
is due to potential drug abuse
15. Taking prohibited medications
16. Participation in a clinical study involving:
• Any anti-amyloid plaque lowering immunotherapy (example, therapeutic monoclonal
antibody or active anti-amyloid vaccine) at any time, unless it can be documented
that the participant was randomized to placebo or never received study drug
• Any immunoglobulin therapy, or vaccine within 6 months before Screening, unless
it can be documented that the participant was randomized to placebo or never
received study drug
• Lecanemab
• Any new chemical entities or investigational drug for AD within 6 months before
randomization unless it can be documented that the participant received only
placebo
• Any other investigational medication or device study in the 8 weeks or 5
half-lives (whichever is longer) of the medication before randomization unless it
can be documented that the participant was in a placebo treatment arm
17. Planned surgery during the pre-randomization phase or within 3 months of
randomization, which requires general anesthesia
For extension phase:
1. Discontinued from the Core Study or from study treatment
2. Under study drug interruption due to ARIA or other AE at the time of transition to the
extension phase
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