Strategies to promote contraception use by female volunteers in Alzheimer's Prevention Initiative Autosomal-Dominant Alzheimer's Disease (API ADAD) Colombia trial

被引:0
|
作者
Bustamante, Christian [1 ]
Martinez, Juan F. [1 ]
Navarro, Alexander [1 ]
Lopera, Margarita [1 ]
Villegas, Gustavo [1 ]
Duque, Sindy [1 ]
Acosta-Baena, Natalia [1 ]
Rios-Romenets, Silvia [1 ]
Lopera, Francisco [1 ]
机构
[1] Univ Antioquia, Neurosci Grp Antioquia, Carrera 51 AN 62-42 Piso 3 Torre B HAMA, Medellin 050010, Colombia
关键词
Contraception in clinical trials; fertility rate; bioethics; crenezumab; CLINICAL-TRIALS; WOMEN;
D O I
10.1177/17407745241264217
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
Background/Aims: Including women of childbearing age in a clinical trial makes it necessary to consider two factors from a bioethical perspective: first, the lack of knowledge about the potential teratogenic effects of an investigational product, and also, the principle of justice not to exclude any population from the benefits of research. The most common way to address this issue is by requiring volunteers to use contraceptives before, during, and a few weeks after the clinical trial. This work presents all the strategies used to promote contraception use and prevent pregnancy during the Alzheimer's Prevention Initiative Autosomal-Dominant Alzheimer's Disease (API ADAD) Colombia clinical trial. Two characteristics of this trial make it of special interest for closely monitoring contraception use. One is that the trial lasted more than 7 years, and the other is that participants could be carriers of the E280A PSEN1 mutation, leading to a mild cognitive impairment as early as their late 30s.Methods: An individual medical evaluation to select the contraception method that best fits the volunteer was carried out during the screening visit, remitting to the gynecologist when necessary. All non-surgical contraception methods were supplied by the sponsor. Staff were trained on contraception counseling, correctly dispensing contraceptive drugs to volunteers, and identifying, reporting, and following up on pregnancies. Two comprehensive educational campaigns on contraception use were performed, and the intervention included all volunteers. In addition, volunteers were asked on an annual survey to evaluate the dispensing procedure. Finally, the effectiveness of these strategies was retrospectively evaluated, comparing by extrapolation the number of pregnancies presented throughout the trial with the General Fertility Rate in Colombia.Results: A total of 159 female volunteers were recruited. All strategies were implemented as planned, even during the COVID-19 contingency. Ten pregnancies occurred during the evaluation period (2015-2021). Two were planned; the rest were associated with a potential therapeutic failure or incorrect use of contraceptive methods for a contraceptive failure of 0.49% per year. Sixty percent of pregnancies led to an abortion, either miscarriage or therapeutic abortion. However, there was not enough data to associate the pregnancy outcome with the administration of the investigational product. Finally, we observed a lower fertility rate in women participating in the trial compared to the Colombian population.Conclusion: The lower rates of contraceptive failure and the decrease in the incidence of pregnancies in women participating in the trial compared to the Colombian population across the 7 years of evaluation suggest that the strategies used in API ADAD Colombia were adequate and effective in addressing contraception use.
引用
收藏
页码:116 / 125
页数:10
相关论文
共 50 条
  • [21] Early molecular events of autosomal-dominant Alzheimer's disease in marmosets with PSEN1 mutations
    Homanics, Gregg E.
    Park, Jung Eun
    Bailey, Lauren
    Schaeffer, David J.
    Schaeffer, Lauren
    He, Jie
    Li, Shuoran
    Zhang, Tingting
    Haber, Annat
    Spruce, Catrina
    Greenwood, Anna
    Murai, Takeshi
    Schultz, Laura
    Mongeau, Lauren
    Ha, Seung-Kwon
    Oluoch, Julia
    Stein, Brianne
    Choi, Sang Ho
    Huhe, Hasi
    Thathiah, Amantha
    Strick, Peter L.
    Carter, Gregory W.
    Silva, Afonso C.
    Sukoff Rizzo, Stacey J.
    ALZHEIMERS & DEMENTIA, 2024, 20 (05) : 3455 - 3471
  • [22] Left frontal hub connectivity delays cognitive impairment in autosomal-dominant and sporadic Alzheimer's disease
    Franzmeier, Nicolai
    Duezel, Emrah
    Jessen, Frank
    Buerger, Katharina
    Levin, Johannes
    Duering, Marco
    Dichgans, Martin
    Haass, Christian
    Suarez-Calvet, Marc
    Fagan, Anne M.
    Paumier, Katrina
    Benzinger, Tammie
    Masters, Colin L.
    Morris, John C.
    Perneczky, Robert
    Janowitz, Daniel
    Catak, Cihan
    Wolfsgruber, Steffen
    Wagner, Michael
    Teipel, Stefan
    Kilimann, Ingo
    Ramirez, Alfredo
    Rossor, Martin
    Jucker, Mathias
    Chhatwal, Jasmeer
    Spottke, Annika
    Boecker, Henning
    Brosseron, Frederic
    Falkai, Peter
    Fliessbach, Klaus
    Heneka, Michael T.
    Laske, Christoph
    Nestor, Peter
    Peters, Oliver
    Fuentes, Manuel
    Menne, Felix
    Priller, Josef
    Spruth, Eike J.
    Franke, Christiana
    Schneider, Anja
    Kofler, Barbara
    Westerteicher, Christine
    Speck, Oliver
    Wiltfang, Jens
    Bartels, Claudia
    Caballero, Miguel Angel Araque
    Metzger, Coraline
    Bittner, Daniel
    Weiner, Michael
    Lee, Jae-Hong
    BRAIN, 2018, 141 : 1186 - 1200
  • [23] Molecular consequences of amyloid precursor protein and presenilin mutations causing autosomal-dominant Alzheimer's disease
    Weggen, Sascha
    Beher, Dirk
    ALZHEIMERS RESEARCH & THERAPY, 2012, 4 (02)
  • [24] Molecular consequences of amyloid precursor protein and presenilin mutations causing autosomal-dominant Alzheimer's disease
    Sascha Weggen
    Dirk Beher
    Alzheimer's Research & Therapy, 4
  • [25] Locus coeruleus integrity is related to tau burden and memory loss in autosomal-dominant Alzheimer's disease
    Dahl, Martin J.
    Mather, Mara
    Werkle-Bergner, Markus
    Kennedy, Briana L.
    Guzman, Samuel
    Hurth, Kyle
    Miller, Carol A.
    Qiao, Yuchuan
    Shi, Yonggang
    Chui, Helena C.
    Ringman, John M.
    NEUROBIOLOGY OF AGING, 2022, 112 : 39 - 54
  • [26] Odor Identification Across Time in Mutation Carriers and Non-Carriers in Autosomal-Dominant Alzheimer's Disease
    Almkvist, Ove
    Larsson, Maria
    Graff, Caroline
    JOURNAL OF ALZHEIMERS DISEASE, 2024, 97 (02) : 587 - 598
  • [27] Autosomal-dominant Alzheimer's disease mutations at the same codon of amyloid precursor protein differentially alter Aβ production
    Suarez-Calvet, Marc
    Belbin, Olivia
    Pera, Marta
    Badiola, Nahuai
    Magrane, Jordi
    Guardia-Laguarta, Cristina
    Munoz, Laila
    Colom-Cadena, Marti
    Clarimon, Jordi
    Lleo, Alberto
    JOURNAL OF NEUROCHEMISTRY, 2014, 128 (02) : 330 - 339
  • [28] The experience acquired during the first prevention clinical trial in Alzheimer's disease in Colombia
    Rios-Romenets, Silvia
    Castano, Marisol Londono
    Villegas, Gustavo
    Munoz, Claudia
    Duque, Sindy
    Cardona, Eugenia
    Luna, Ernesto
    Lopez, Hugo
    Lopez, Liliana
    Valencia, Yury
    Gallego, Erika
    Ramos, Claudia
    Giraldo, Margarita
    Acosta-Baena, Natalia
    Sink, Kaycee
    Tariot, Pierre
    Reiman, Eric
    Lopera, Francisco
    JOURNAL OF THE NEUROLOGICAL SCIENCES, 2023, 455
  • [29] Cortical thickness across the lifespan in a Colombian cohort with autosomal-dominant Alzheimer's disease: A cross-sectional study
    Fox-Fuller, Joshua T.
    Torrico-Teave, Heirangi
    Uquillas, Federico d'Oleire
    Chen, Kewei
    Su, Yi
    Chen, Yinghua
    Brickhouse, Michael
    Sanchez, Justin S.
    Aguero, Cinthya
    Jacobs, Heidi I. L.
    Hampton, Olivia
    Guzman-Velez, Edmarie
    Vila-Castelar, Clara
    Aguirre-Acevedo, Daniel C.
    Baena, Ana
    Artola, Arabiye
    Martinez, Jairo
    Pluim, Celina F.
    Alvarez, Sergio
    Ochoa-Escudero, Martin
    Reiman, Eric M.
    Sperling, Reisa A.
    Lopera, Francisco
    Johnson, Keith A.
    Dickerson, Bradford C.
    Quiroz, Yakeel T.
    ALZHEIMER'S & DEMENTIA: DIAGNOSIS, ASSESSMENT & DISEASE MONITORING, 2021, 13 (01)
  • [30] The Alzheimer's Prevention Initiative (API) Generation Program: Evaluating the Efficacy of the BACE-1 Inhibitor CNP520 in Preclinical Alzheimer's Disease
    Tariot, Pierre
    Lopez-Lopez, Cristina
    Caputo, Angelika
    Thomas, Ronald G.
    Langbaum, Jessica
    Lenz, Robert
    Vargas, Gabriel
    Viglietta, Vissia
    Reiman, Eric M.
    Graf, Ana
    NEUROPSYCHOPHARMACOLOGY, 2017, 42 : S143 - S144