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Trial · Interventional

CompletedPhase 2Registry data

Safety, Tolerability and Efficacy Study to Evaluate Subjects With Mild Cognitive Impairment

Overview

Status
Completed
Phase
Phase 2
Enrollment
144 participants (actual)
Sponsor
Allon Therapeutics · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Jan 2007
Primary completion
Jan 2008
Completion
Jan 2008
First posted
17 Jan 2007 (estimated)
Last update posted
24 Oct 2012 (estimated)
Conditions
Mild Cognitive Impairment, So Stated

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200720082009
  1. Ph 2

    Safety, Tolerability and Efficacy Study to Evaluate Subjects With Mild Cognitive Impairment

    NCT00422981

    Jan 2007 to Jan 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to find out if different doses of Investigational Drug are safe, tolerable, and if they have an effect on Mild Cognitive Impairment (MCI).

Interventions

  • AL-108Drug
  • AL-108Drug
  • PlaceboDrug

Arms3

  • Active comparator

    AL-108 5 mg

    5 mg QD

  • Active comparator

    AL-108 15 mg

    15 mg BID

  • Placebo comparator

    Placebo

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change from baseline to Week 12 on the Composite Memory Variable

    Time frame · 12 weeks

Secondary outcomes(2)
  1. Changes in the Composite Memory Variable from baseline to weeks 4, 8, and 16

    Time frame · 16 weeks

  2. Changes in test battery individual items from baseline to endpoints (weeks 4, 8, 12, and 16).

    Time frame · 16 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2024

2 results

Davunetide sex-dependently boosts memory in prodromal Alzheimer's disease.

Gozes et al. 2024Translational psychiatrycited by 19

PMID 39358355PMC11446927DOI 10.1038/s41398-024-03118-0PUB-39358355

Free to read · publisher termsCC BY-NC-ND2 results

Indexing hint: Randomized controlled trial · 2013

3 results

A double-blind, placebo-controlled, ascending-dose, randomized study to evaluate the safety, tolerability and effects on cognition of AL-108 after 12 weeks of intranasal administration in subjects with mild cognitive impairment.

Morimoto et al. 2013Dementia and geriatric cognitive disorderscited by 93

PMID 23594991DOI 10.1159/000348347PUB-23594991

Full text at the publisher3 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 55 Years up to 85 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Is male or female, at 55-85 years of age (inclusive) at screening * Self-reported memory complaint, corroborated by spouse or companion as appropriate. * Wechsler Memory Scale III (WMS-III) age-adjusted Logical Memory II score ≤ 5. * Mini-Mental State Exam (MMSE) ≥24. * Center for Epidemiologic Studies-Depression (CES-D) score \<27. * Normal thyroid function, defined as TSH, T3 and T4 within normal limits. * Agree not to consume alcoholic beverages within 8 hours of each study visit. * Willing and able to sign informed consent and complete the CTB and all other tests and procedures as listed in the protocol. * Fluently reads and speaks English. * Female subjects must be surgically sterile or post-menopausal for at least 2 years. If \<2 years post-menopausal, then a follicle stimulating hormone (FSH) ≥40 mIU/mL must be obtained. Exclusion Criteria: * Subjects who have any significant, untreated psychiatric illness or any CNS condition (such as schizophrenia, Parkinson's disease, stroke, etc.) that could interfere with the study evaluations or procedures or which poses an additional risk. Subjects with a history of uncomplicated depression may participate if in remission and on a stable dose of antidepressant medication for at least 2 months. * History of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities. * History of alcohol or substance abuse or dependence within the past year. * Acute infective sinusitis. * History or presence of an abnormality of the external or internal structures of the nose or nasopharynx, except for surgical correction of the nasal septum or a "broken nose" at least 2 years previously, or surgical repair of cleft palate when \<30 years of age. * Use of medications that are known to cause frank obtundation of cognition * Use of any approved or investigational medication for Alzheimer's Disease within 3 months of screening * History of or current significant systemic disease judged to interfere with the study evaluations or likely to be a safety concern. * Untreated sleep apnea or treatment for sleep apnea for \<3 months. * Abnormal clinical laboratory test results, specifically: Alanine transaminase (ALT) or aspartate transaminase (AST) \>2 х the upper limit of normal (ULN),Hematology \<80% the lower limit of normal, Creatinine ≥2 mg/dL and ,Other clinical laboratory values or vital signs considered clinically significant in the opinion of the Investigator. * Treatment with any investigational drug, biologic, or device within the previous 30 days prior to screening. * Surgery involving general anesthesia within the past 3 months or planned surgery requiring general anesthesia during the study period.

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